Exam Code: NE-BC Practice exam 2023 by Killexams.com team
NE-BC ANCC Nurse Executive Certification

Exam : NE-BC
Exam Name : ANCC Nurse Executive Certification
Number of Questions : 175
Scored Questions : 150
Unscored Questions : 25

Category Domains of Practice No. of Questions Percent
I Structures and Processes 27 18%
II Professional Practice 55 37%
III Leadership 33 22%
IV Knowledge Management 35 23%
Total 150 100%

There are 175 questions on this examination. Of these, 150 are scored questions and 25 are pretest questions that are not scored. Pretest questions are used to determine how well these questions will perform before they are used on the scored portion of the examination. The pretest questions cannot be distinguished from those that will be scored, so it is important for a candidate to answer all questions. A candidate's score, however, is based solely on the 150 scored questions. Performance on pretest questions does not affect a candidate's score.

I. Structures and Processes (18%)
A. Human Capital Management
Knowledge of:
1. Federal and state laws (e.g., Family and Medical Leave Act [FMLA], American with Disabilities Act [ADA], Fair Labor Standards Act [FLSA], wage and hour laws, equal employment opportunities, Occupational Safety and Health Administration [OSHA],
workers compensation)
2. Labor relations (e.g., collective bargaining, contract negotiations, grievances and arbitrations, National Labor Relations Board [NLRB])
3. Resource utilization (e.g., cross training, job descriptions )
4. Principles associated with human resources (e.g., employee assistance and counseling, compensation, benefits, coaching, performance management)
5. Organizational culture (e.g., just culture, transparency)
6. Organizational structure (e.g., chain of command, organizational chart, span of control)
Skills in:
7. Participating in developing and modifying administrative policies and procedures
8. Implementing and enforcing administrative policies and procedures (e.g., monitoring compliance)
9. Providing feedback on effectiveness of administrative policies and procedures
10. Evaluating the effectiveness of roles based on changing needs in the health care environment (e.g., new or expanded job descriptions, professional development)
B. Financial Management
Knowledge of:
1. Basic financial and budgeting principles (e.g., revenue cycle, supply and labor expenses, productivity, depreciation, return on investment [ROI], cost-benefit analysis)
2. Reimbursement methods (e.g., payor systems, pay for performance, payment bundling, value-based purchasing)
3. Contractual agreements (e.g., vendors, materials, staffing)
4. Principles of staffing workload (e.g., full-time equivalents [FTE], hours per patient day, skill mix)
Skills in:
5. Developing a budget (e.g., operational, capital)
6. Analyzing variances and managing a budget (e.g., operational, capital)
7. Efficient resource utilization (e.g., contractual agreements, outsourcing)
8. Determining appropriate staffing workload
C. Health and Public Policy
Knowledge of:
1. Legal issues (e.g., fraud, whistle-blowing, the Health Insurance Portability and Accountability Act [HIPAA], corporate compliance, electronic access and security, harassment, malpractice, negligence)
2. Consumer-driven health care (e.g., public reporting, Community Health Needs Assessment [CHNA], Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS], Healthgrades)
3. Emergency planning and response
4. Planning and responding to internal and external disasters
5. Planning and responding to health and public policy issues
6. Assessing, addressing, and preventing legal issues (e.g., violations, fraud, whistleblowing, the Health Insurance Portability and Accountability Act [HIPAA], corporate compliance, electronic access and security, harassment)

II. Professional Practice (37%)
A. Care Management/Delivery
Knowledge of:
1. Health care delivery models and settings (e.g., accountable care organization [ACO], patient-centered medical home [PCMH], nurse-led clinic, telehealth, e-health, inpatient, ambulatory care, home health, rehabilitation, etc.)
2. Laws, regulations, and accrediting bodies (e.g., The Joint Commission, Centers for Medicare and Medicaid Services, Nurse Practice Act)
3. Standards of nursing practice (e.g., clinical practice guidelines, clinical pathways, ANA Scope and Standards of Practice, Nurse Practice Act)
Skills in:
4. Establishing staffing models (e.g., primary care nursing, team nursing, nurse-patient ratios, skill mix, acuity)
5. Designing workflows based on care delivery model and population served (e.g., patient centered medical home [PCMH], interdisciplinary team, case management, disease management, throughput, staffing assignment and scheduling)
6. Developing policies and procedures that ensure regulatory compliance with professional standards and organizational integrity
B. Professional Practice Environment and Models
Knowledge of:
1. Professional practice models
2. Role delineation (e.g., credentialing, privileging, certification)
3. Professional practice standards (e.g., ANA Scope and Standards of Practice, Nurses Bill of Rights, Nurse Practice Act)
4. Employee performance feedback (e.g., coaching, performance appraisal, Just Culture)
Skills in:
5. Developing clinical staff (e.g., orientation, continuing education, competency validation, performance appraisal, peer review, mentoring, planning, lifelong learning)
6. Creating a professional environment for empowered decision making (e.g., shared governance, staff accountability, critical thinking, civility)
7. Recruiting, recognizing, and retaining staff
8. Providing internal and external customer service (including service recovery)
9. Creating a vision for professional nursing practice that promotes patient and family centered care
C. Communication
Knowledge of:
1. Communication principles (e.g., active listening, reflective communication, two-way communication, interviewing)
2. Communication styles (e.g., persuasive, assertive, passive, aggressive, passiveaggressive)
3. Negotiation concepts and strategies (e.g., compromising, collaborating, win-win)
4. Communication processes that support safe patient care (e.g., documentation, handoffs or hand-overs, bedside reporting, incident reporting, reporting sentinel events)
Skills in:
5. Communicating using verbal (e.g., oral and written) and nonverbal methods (e.g., body language, eye contact, active listening)
6. Facilitating collaboration to achieve optimal outcomes (e.g., team building, group dynamics, leveraging diversity)
7. Selecting the appropriate communication method for the audience and situation (e.g., email, role playing, presentation, reports, staff meeting, board meeting, one-on-one conversation, patient/family council, consumer feedback)
8. Conflict management

III. Leadership (22%)
A. Leadership Effectiveness
Knowledge of:
1. Key elements of a healthy work environment
2. Leadership concepts, principles, and styles (e.g., pervasive leadership, servant leadership, situational leadership, appreciative inquiry, culture of transparency, change management theories)
3. Coaching, mentoring, and precepting
4. Emotional intelligence
5. Sources of influence and power
Skills in:
6. Self reflection and personal leadership evaluation
7. Integrating diversity and sensitivity into the work environment
8. Change management
9. Building effective relationships through listening, reflecting, presence, communication, and networking
10. Succession planning
11. Creating an environment to engage and empower employees
B. Strategic Visioning and Planning
Knowledge of:
1. Strategic planning principles (e.g., alignment of nursings strategic plan with the organizational plan, SWOT analysis, components of strategic planning)
2. New program development (e.g., proposals, pro forma, business plans, marketing)
3. Trends that effect nursing practice and the healthcare environment
4. Communicating and building consensus and support for the strategic plan
5. Establishing baselines for processes (i.e., measuring current performance)
6. Evaluating processes and outcome measures over time
7. Project management to support/achieve the strategic plan (e.g., planning, implementing, and monitoring action plans)
C. Ethics and Advocacy
Knowledge of:
1. Ethical principles
2. Business ethics (e.g., corporate compliance, privacy)
3. ANAs Code of Ethics
4. Patients Bill of Rights
Skills in:
5. Advocating for patients (e.g., patient rights, access, and safety)
6. Advocating for staff (e.g., healthy work environment, equipment, staffing)
7. Advocating for the nursing profession (e.g., professional organizations, promoting education, certification, legislative influence)

IV. Knowledge Management (23%)
A. Quality Monitoring and Improvement
Knowledge of:
1. Systems theory
2. Continuous performance improvement (The Plan-Do-Study-Act [PDSA] Cycle, Lean, root cause analysis, tracer methodology)
3. Process and outcome measures (e.g., clinical, financial, safety, patient satisfaction, employee satisfaction)
4. Culture of safety (e.g., risk management, employee engagement, employee safety technologies [patient lifts], patient safety technologies [bar coding])
Skills in:
5. Creating a culture of continuous performance improvement
6. Translating data into information (including use of internal and external benchmarks), and disseminating it at various levels within the organization
7. Evaluating and prioritizing outcomes of care delivery (e.g., nurse sensitive indicators, ORYX indicators, National Patient Safety Goals, core measures)
8. Selecting the appropriate continuous performance improvement technique
9. Action planning to address identified quality issues
B. Evidence-based Practice and Research
Knowledge of:
1. Institutional Review Board (IRB) requirements (e.g., protection of human research subjects)
2. Research and evidence-based practice techniques (e.g., literature review, developing research questions, study methods and design, data management, levels of evidence)
3. Distinguish between performance improvement, evidence-based practice, and research
4. Creating a culture and advocating for resources that support research and scholarly inquiry (e.g., journal club, grant writing, research councils, research participation)
5. Communicating research and evidence-based findings to internal and external stakeholders
6. Incorporating evidence into policies, standards, procedures and guidelines
7. Evaluating and incorporating new knowledge and published research findings into practice
C. Innovation
Knowledge of:
1. Clinical practice innovation
2. Leadership practice innovation
Skills in:
3. Creating a culture that values, encourages, and recognizes new and innovative ideas that benefit the patient, family, organization, or community
4. Developing a framework for implementing innovations (e.g., small tests of change, pilot studies)
5. Leveraging diversity to encourage new and innovative ideas or new patterns of thinking
6. Evaluating and applying technology to support innovation

ANCC Nurse Executive Certification
Medical Certification information search
Killexams : Medical Certification information search - BingNews https://killexams.com/pass4sure/exam-detail/NE-BC Search results Killexams : Medical Certification information search - BingNews https://killexams.com/pass4sure/exam-detail/NE-BC https://killexams.com/exam_list/Medical Killexams : Online Medical Assistant Certification Program

Obtaining a CPC, CCA, or CBCS certification implies that an individual has met competencies in the field of medical billing and coding. Certification is invaluable to the student's career goals. Students have an opportunity to make confident, informed decisions about the national certification they prefer.

The Certified Professional Coder (CPC) exam is offered by the American Academy of Professional Coders (AAPC). It is the gold standard entry-level coding certification for physician, or professional fee, coders.

The Certified Coding Associate (CCA) is offered by the American Health Information Management Association (AHIMA). It is an entry-level medical coding certification across all settings--physician practices and inpatient hospital.

The Certified Billing and Coding Specialist (CBCS) is offered by the National Healthcareer Association (NHA) and is currently an entry-level medical billing certification for physician practices. In the summer of 2021, the exam will transition to an entry-level billing and coding certification, with the inclusion of ICD-10-CM, CPT, and HCPCS Level II testing.

Mon, 31 Jan 2022 02:17:00 -0600 en text/html https://www.utsa.edu/pace/online/certified-medical-administrative-assistant-medical-billing-coding.html
Killexams : Certificate in Medical Billing and Coding

With its fully online format, Drexel University’s accredited online Certificate in Medical Billing and Coding is designed with your career in mind. The distinguished faculty from Drexel’s College of Nursing and Health Professions have carefully designed the medical billing and coding curriculum to provide the skills and education you need to be successful in the rapidly evolving fields of medical billing and medical coding. Whether you are looking to start your career, or already have healthcare experience working in a hospital, clinic, medical office, nursing home or insurance organization but need the skills and the medical billing and coding certification credentials to take your career to the next level, Drexel’s program will help you to achieve the next step in your journey.

Did You Know?
In 2007, 90% of physicians in the United States manually updated patient records and stored them in color-coded paper files. By 2018, those same 90% completed the transition from paper medical records to electronic health records (EHRs). This trend will drastically Boost the way patient medical records are accessed and shared, creating a more efficient, cost effective, and safe environment.

Why is Drexel’s online Certificate in Medical Billing and Coding program a great investment?

  • This program is now financial aid eligible.
  • Drexel’s College of Nursing and Health Professions’ medical coding training program is one of the most in-depth of its kind in the country.
  • The program’s comprehensive curriculum covers learning principles related to the four main coding manuals - CPT, HCPCS, ICD-10-CM, and ICD-10-PCS.
  • You will acquire a solid foundational understanding of medical billing, anatomy, software and terminology, as well as physician and hospital-based medical coding.
  • Upon completing the program, you will be qualified to sit for the associated national certification exams, including the:
    • American Medical Billing Association - Certified Medical Reimbursement Specialist (CRMS) Board Exam
    • AAPC - Certified Professional Coder (CPC®), Certified Outpatient Coder (COC™) [formerly CPC-H®], Certified Inpatient Coder (CIC™), or Certified Professional Medical Auditor (CPMA®) Board Exam
    • American Health Information Management Association - Certified Coding Associate (CCA®), Certified Coding Specialist (CCS®), or Certified Coding Specialist Physician-Based (CCS-P®) Board exam - The CCS & CCS-P credentials require experience in addition to the education.
  • You may also apply the 30 credits you earn as free electives toward Drexel’s fully online BS in Health Services Administration program.
  • This program is now financial aid eligible.

What is medical billing and coding?

According to the AAPC, “medical billers and medical coders are the healthcare professionals in charge of processing patient data such as treatment records and related insurance information.” When a patient receives medical treatment, there are fees associated with each service that is provided. Medical coders are the professionals tasked with providing the insurance company with the proper treatment and diagnosis codes so that the correct reimbursements are assigned. Medical billers then join the process and are responsible for the submission of the insurance claims and ultimately accountable for ensuring that payment is received.

What does a medical biller and coder do?

Medical billing and medical coding specialists play a crucial role in the business side of the healthcare industry. In addition to properly coding and processing healthcare claims to ensure insurance companies and providers are correctly reimbursed, you will be responsible for creating accurate patient records to avoid billing errors and provide a record of treatment for future evaluation. The switch to ICD-10 coding is making a complex industry even more intricate. Drexel’s online Certificate in Medical Billing and Coding provides a comprehensive curriculum that introduces you to the learning principles you need to successfully prepare for your future career. This includes the four main coding manuals - CPT, HCPCS, ICD-10-CM, and ICD-10-PCS.

What are the national medical billing and coding certification exams?

Upon completing the program, you will be qualified to sit for the associated national certification exams, including the:

  • American Medical Billing Association - Certified Medical Reimbursement Specialist (CRMS) Board Exam
  • AAPC - Certified Professional Coder (CPC®), Certified Outpatient Coder (COC™) [formerly CPC-H®], Certified Inpatient Coder (CIC™), or Certified Professional Medical Auditor (CPMA®) Board Exam
  • American Health Information Management Association - Certified Coding Associate (CCA®), Certified Coding Specialist (CCS®), or Certified Coding Specialist Physician-Based (CCS-P®) Board exam - The CCS & CCS-P credentials require experience in addition to the education.

Earn credits toward a BS in Health Services Administration degree

Through completing the Certificate in Medical Billing and Coding, you'll earn 30 quarter credits that may be applied as free electives toward our fully-online BS in Health Services Administration program.

How long do you have to go to school to become a medical coder or medical biller?

While it depends on the number of courses you take per quarter, most students complete this program within 18 months. However, you'll be prepared to sit for the associated certification exams after successful completion of Part II of any of the billing and coding courses. As a result, you can achieve national certification even before completing the program.

What classes are required for medical billing and coding?

Drexel's online medical billing and coding courses focus on the four most commonly used coding manuals—CPT, HCPCS, ICD-10-CM, and ICD-10-PCS—providing all the relevant, up-to-date information you need to take the national certification exams with confidence. This includes beginning the program with a course on anatomy and another in medical terminology to ensure you have the proper introduction to the medical billing and coding field prior to starting your coding courses. The skills you’ll learn throughout the program are fully applicable to a wide array of medical billing and coding positions, meet all industry requirements, and can be leveraged wherever you go, serving as a valuable foundation for future endeavors.

What is ICD-10?

The International Classification of Diseases (ICD) is the recognized standard international diagnostic classification system for documenting and monitoring illnesses. It allows health organizations around the world to compare, monitor, and share data in a consistent and standardized Endorsed by the World Health Assembly in 1990 and adopted by the World Health Organization (WHO) members in 1994, the current, endorsed version is the tenth edition of ICD.  ICD-10 contains more than 70,000 different codes for diseases, symptoms, and diagnoses, which is significantly up from the 14,000+ codes that were contained in its predecessor, ICD-9. The adoption of ICD-10 in the United States took place on October 1, 2015. Recently, development has begun on the next edition, ICD-11, which is expected to be implemented in 2022.

Designed for your Medical Billing and Coding Career

Are you new to the fields of medical billing and medical coding? Drexel’s certificate is designed to not only provide the foundational knowledge you need but prepare you for the national certifications that stand out to employers.

Already experienced in Medical Billing and Coding? If you’re a current billing or coding professional looking for a training program that can take your career to new heights and won’t interfere with your current schedule, look no further. Designed with your career in mind, Drexel’s certificate is a fully-online, 30-quarter credit, 10-course program that has the flexibility to align the curriculum to the credentials you need to take your career to the next level.

What jobs can I get with a medical billing and coding certificate?

The Bureau of Labor Statistics (BLS) projects a 13% increase in medical records and health information technician jobs by 2026. That results in more than 27,800 new jobs between 2016 and 2026.

Those who have completed the Certificate in Medical Billing and Coding program can look forward to career opportunities in:

  • Medical Billing
  • Medical Coding
  • Medical Auditing
  • Medical Records
  • Medical Transcription
  • Practice Management and Education
  • And many more...

Organizations such as inpatient and outpatient hospitals, private medical practices, nursing care facilities, administrative and support services, and professional, scientific and technical services all require medical billing and coding professionals in order to be successful.

How much does a medical biller and coder make in a year?

According to the BLS, professionals in the medical billing and coding fields can potentially earn a median annual salary of $39,180 per year or $18.83 per hour for medical records and health information technicians and $35,250 per year or $16.95 per hour for medical transcriptionists.

Can you work from home as a medical biller and coder?

Work from home career opportunities do exist for medical billing and coding professionals. However, these types of positions are harder to earn and are most often awarded to professionals with extensive professional experience.

This program is only available on a part-time basis.
State restrictions may apply to some programs.

Wed, 03 Feb 2021 04:12:00 -0600 en text/html https://drexel.edu/cnhp/academics/certificates/Certificate-Medical-Billing-and-Coding/
Killexams : How To Earn Medical Billing And Coding Certification Online For Cheap

Editorial Note: We earn a commission from partner links on Forbes Advisor. Commissions do not affect our editors' opinions or evaluations.

For individuals who are comfortable in front of a computer and have the organizational skills to convert large amounts of medical information into code, medical billing and coding can be a promising career path. As the population ages, this profession is playing an increasingly important role in the healthcare sector.

You can obtain medical billing and coding certification online within a year or less. Accredited online medical billing and coding courses cover basic medical terminology, coding and classification and coding and billing software. This knowledge prepares you to pass a certification exam and become a qualified job candidate.

Below, we recommend what to look for in medical billing and coding schools and explain how to find a low-cost medical coding and billing online program that meets your needs.

Southern New Hampshire University

Take the next step in your health career with a program from Southern New Hampshire University.

Learn More

What do Medical Billers and Coders Do?

What is medical billing and coding, exactly? Medical billers and coders process medical records and health insurance paperwork in hospitals, doctors’ offices and other healthcare facilities. Coders assign preset codes to medical procedures and treatments. Billers then use that code to prepare patient bills and insurance claims.

These two professions overlap significantly, with medical billers regularly handling medical coding and vice versa. Most employers in the field are looking for workers with both skill sets.

Acting as conduits between doctors and their patients and between medical billing offices and insurance companies, medical billers and coders play an essential role in an increasingly digitized healthcare environment.

But is medical billing and coding hard? If you’re detail-oriented and you complete the right training program, this career isn’t particularly difficult.

Medical Billing and Coding Career

Work Environment

Medical billers and coders work in every type of medical facility, from clinics and doctors’ offices to hospitals and nursing homes. They also work for insurance companies, law firms and government agencies.

Because this job entails significant time in front of a screen, a standard office environment is typical—but remote work is becoming a more common option for this information-based, digital field.

Salary and Job Growth

In 2021, the annual median salary for medical records specialists, including billers and coders, was $46,660, according to the U.S. Bureau of Labor Statistics (BLS). The BLS projects employment for these workers to grow by 7% from 2021 to 2031.

How To Find Low-Cost Medical Coding And Billing Programs

If you’re concerned about how much medical billing and coding online courses cost, there’s no need to worry. Affordable and even free medical billing and coding certification programs are out there. Here’s where to find them.

Explore Online Options

There are clear benefits to taking an online course for your medical billing and coding certification. First, the online route offers cost savings due to lower tuition fees, no commuting expenses and the elimination of ancillary costs like room and board at an in-person institution.

Then there’s the significant gain in flexibility. Online learning often allows you to complete your coursework at your own pace and on your own time, from any location with a decent internet connection. Another noteworthy advantage is that remote learning can increase your familiarity with job-relevant technology and digital environments.

Online learning allows you to earn your certification more quickly, too, with some accelerated programs promising job-ready credentials within weeks. But not all shorter courses include medical coding in their curricula, and not all come from properly accredited institutions.

Consider Local Colleges

In-state institutions may offer tuition discounts to state residents. Again, remember that you want a program from an accredited school or institution, meaning the provider meets rigorous standards set by a recognized accrediting body. Online resources can help you determine whether there’s an accredited school with a medical billing and coding program near you.

Research Scholarships and Grants

Don’t let the cost of obtaining your medical billing and coding certificate or diploma deter you; financial aid is available. Health information management associations in many states—Georgia and New York, for instance—offer assistance to residents attending accredited degree programs. Individual medical billing and coding programs may also offer scholarships and other forms of financial aid.

Be Sure the Program Prepares You for Certification

To ensure your program meets requirements for medical billing and coding certification, it should provide materials and coursework that are geared toward a specific certification exam.

As you research your program, look for references to credentialing exams like the Certified Coding Associate (CCA)® and Certified Coding Specialist (CCS)® certification exams administered by the American Health Information Management Association, or the Certified Professional Coder (CPC)® exam run by the American Academy of Professional Coders.

Check if the exam Fee is Included in Tuition

At the time of writing, the CPC exam mentioned above costs $299 for the online version and $349 for an in-person test. However, some courses include this examination fee in their tuition costs, so check whether your prospective course includes exam fees as part of the package.

Frequently Asked Questions (FAQs) About Medical Coding and Billing

Is medical billing and coding difficult?

Medical billing and coding is a detail-oriented profession that involves handling large amounts of complex data. While that may sound daunting at first, remember that your coursework for certification will teach you the codes and train you in the software that you’ll be using every day.

How many months is a medical coding course?

Earning a medical billing and coding certification can take anywhere from four months to a year. The alternative to certification is an associate or bachelor’s degree in healthcare administration, accounting or business administration—any of which can take up to three years to acquire.

How much does a medical coder make?

As per the BLS, the median annual wage for medical records specialists was $46,660 ($22.43 per hour) as of May 2021. Compensation for the top 10% of earners in the field exceeded $74,200 per year.

Mon, 06 Feb 2023 12:15:00 -0600 Jeff Tompkins en-US text/html https://www.forbes.com/advisor/education/medical-billing-and-coding-certification-online/
Killexams : Medical Imaging Certificate

Gain High-demand Medical Imaging Skills

It's easy to see why the call for medical imaging professionals continues to grow. Imaging technology, using both ionizing and non-ionizing radiation, is vital to medical diagnostics and therapeutics. Michigan Tech's Medical Imaging on-campus Certificate gives new graduates and experienced industry professionals thorough grounding in the basic skills essential to the principles, development, and characterization of medical imaging devices.

Who is This Certificate For?

This certificate is for qualified professionals who want to enhance their skill set and can be a foundation to continue toward a graduate degree. It is also valuable for degree-seeking students looking to develop a concentration that gives them an edge in their career path.

What You Need to Know

The graduate certificate in Medical Imaging program allows students to delve deeper into imaging requirements in biomedical applications, engineering and physics principles to specific biomedical imaging problems, imaging device development and theory of operation, and design of medical imaging tools. Develop an appreciation of the design, development, and applications of diagnostic and/or therapeutic imaging devices for biomedical applications. Get familiar with how to apply these skills in real-world problems and implement application-specific solutions.


To enroll in this certificate program, students must have a bachelor's degree in any engineering discipline. See complete admissions requirements.

Accelerated Option

Michigan Tech Bachelor's + 1 Semester = Accelerated Graduate Certificate

Current Michigan Tech undergraduates or accurate alumni, get started right away. Our accelerated graduate certificates are a fast, affordable way to add graduate credentials to your bachelor's degree in as little as one semester. Be more marketable in your industry or prepare for your master's degree. Explore accelerated certificate options.


This graduate certificate requires a minimum of 10 total credits. Students may apply the credits earned for this certificate toward a graduate degree at Michigan Tech.

Related Certificates

You might also be interested in:

Wed, 12 May 2021 11:37:00 -0500 en text/html https://www.mtu.edu/gradschool/programs/certificates/medical-imaging/
Killexams : Understanding Japan’s Medical Device Certification System



Japan's consumption of medical devices makes it an attractive market for global medical device manufacturers. But manufacturers hoping to sell their devices in Japan must pay careful attention to the revised Pharmaceutical Affairs Law (PAL). It aligns Japan's regulatory requirements more closely with those of other advanced nations. In this article, we examine the changes, challenges, and benefits of the revised PAL.


After the financial slowdown in the mid-1990s, Japan's economic fortunes have begun to increase—and so has the country's appetite for medical devices. In 2004, medical devices constituted an estimated $19 billion–market in Japan, larger than all other Asian markets. During the next few years, as Japan's economy continues to grow, imports of foreign medical devices are expected to grow by 5–8% annually and continue to represent 10% of the world market for medical devices.1


Despite the favorable prospects for exporting medical devices to Japan, all foreign medical manufacturers must still contend with a legal requirement stipulating that all medical products be registered with the Japanese Ministry of Health, Labour, and Welfare (MHLW), Japan's equivalent of FDA. This law has become increasingly instrumental to Japan's device market because products grandfathered in prior to 2005 must comply with the revised PAL when their existing Shonin (regulatory approval) expires. Manufacturers will also have to deal with the PAL when they need to make a significant change to a product that would require premarket clearance. In Japan, medical device manufacturers and importers are also expected to demonstrate certain behaviors associated with corporate social responsibility. Hence, the Japanese government requires foreign device manufacturers to maintain a physical presence in Japan so that remedies for identified safety problems with a device can be applied immediately.

Amended Legislation for Medical Devices

The PAL is the most important legislation for foreign device firms hoping to sell products in the Japanese market. In July 2002, the Japanese House of Representatives passed the amended PAL, which is applicable to all medical devices, drugs, quasidrugs, and cosmetics entering the Japanese market. It became effective April 1, 2005, and has the following objectives:

  • To enhance safety measures for medical devices sold in Japan.
  • To strengthen postmarketing safety measures for medical devices.
  • To align Japan's medical device regulatory system with prevailing international systems.

In order to apply for the necessary regulatory clearance to market a device, manufacturers outside of Japan must appoint a marketing authorization holder (MAH) as their representative in Japan. The MAH may be a subsidiary of the manufacturer through common ownership or may be an independent entity, but the manufacturer must establish a detailed contract with the MAH in accordance with the requirements of the amended PAL and related ministerial ordinance (MO).

If a manufacturer wishes to have its subsidiary or sales office as the MAH, then the subsidiary must be licensed as an MAH by the appropriate prefecture (comparable to county) government in Japan in accordance with MOs 135 and 136. This enables the MAH to be accredited by MHLW to apply for PAL certification. Only these legal license holders can apply for and hold PAL certification of medical devices. For a foreign manufacturer to become an MAH on its own, it must be accredited as a special MAH by the Pharmaceuticals and Medical Devices Agency (PMDA), an executive arm of MHLW also known as Kiko. The manufacturer must also nominate a representative in Japan.

Under the amended PAL, foreign manufacturers of all classes of medical devices are also required to obtain foreign manufacturing accreditation for their manufacturing facilities. This accreditation can only be obtained by applying through the MAH to PMDA. MO 2 outlines the requirements for accreditation. Manufacturers that sold products in Japan before the PAL was amended may have been granted temporary foreign manufacturing accreditation, which means they can delay their application for accreditation until 2008. After 2008, foreign manufacturing facilities must be reaccredited under the new regulation (MO 2).

The Quality Management Systems Ministerial Ordinance on Medical Devices and In Vitro Diagnostics (MO 169, also known as the QMS ordinance), implemented in 2005, lacked certain requirements integral to ISO 13485:2003. These requirements, which outlined management responsibility, risk management in production, design controls (if applicable), criteria for suppliers, process validation, and analysis of data, were not mandatory in Japanese regulations until April 2007. Therefore, it is possible that early accreditation assessments to MO 169 did not include these elements. Manufacturers with a current Japanese QMS and those submitting new applications should ensure that these requirements are properly satisfied in time for surveillance visits.

Another key change brought by the revised PAL is that Class II medical devices, which are designated as controlled medical devices, have now shifted from ministerial-level approval to designated third-party approval (see Table I). In other words, MAHs for Class II medical devices can obtain a certification of product conformance from a registered third-party certification body rather than directly from PMDA. This change allows manufacturers to get their products certified faster and also tap into the technical expertise of third-party certification bodies. However, only certain designated Class II medical devices can benefit from the third-party approval process. A Japanese Industrial Standard (JIS)—a mandatory performance standard—must be established for a medical device to be eligible. In many instances, the mandatory JIS standard is equivalent to an IEC standard, such as the second edition of IEC 60601-1. Class II devices for which no JIS standard has been established may not use a third-party certification body and must apply to PMDA directly.

Out of the 4044 total device types identified by MHLW, only 1785 are designated as Class II, and less than half of those are currently designated as controlled medical devices eligible for third-party approval. The JIS conformity assessment standard and essential requirements are designated by MHLW by device type, which enables third-party assessment of such Class II devices. Article 41 of the revised PAL requires the minister to establish necessary standards after seeking the opinion of the Pharmaceutical Affairs Food and Sanitation Council (also called Bukai). The list of devices eligible for third-party approval is continually growing as MHLW approves additional essential-principles checklists.

An application for a Class II device license requires an assessment of the quality management system of the device manufacturer (including foreign manufacturers) to the requirements of MO 169. This ordinance is based entirely on ISO 13485:2003, with some additional requirements for the Japanese market. Manufacturers of Class II active medical devices may include or exclude requirements for design and development depending on the designation by MHLW. This assessment may be carried out by local assessors trained on Japanese requirements and qualified by the third party. Some third parties, because of the location of their audit staff, must dispatch their assessors from Japan and coordinate logistics, including travel and lodging for the audit team and its translators.

Obtaining a device license also involves an evaluation of the technical documentation for the medical device. This is similar to the requirements outlined in the Global Harmonization Task Force's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices document. Japanese regulations may also require additional information, such as proof of compliance with the JIS performance standard. The MAH is required to present this information in Japanese to the third-party assessor.

Selecting a Third-Party Approval Body

There are a variety of services provided by third parties. By carefully choosing a third-party approval body, an MAH can take advantage of additional accreditations and services that the third-party organizations offer. Some third parties allow the supporting documents, which demonstrate a device's conformity to the applicable JIS or IEC standards, to be assessed in English (to give a degree of confidence) before undergoing a costly translation process. Foreign manufacturers may want to consider this service when their original technical file has already been approved by another public health authority. Allowing supporting documents to be assessed in English would ensure that all requirements of the Japanese regulations are included in a device's technical file, since some requirements may be specific to the Japanese regulatory system.

A medical device company should also consider testing requirements when choosing its third party. Not all JIS standards are based on IEC requirements. If a device has already been tested for markets outside of Japan, it is possible that some of the mechanical and engineering decisions can be made based on previous tests, especially if the device is not electrical (nonactive) or if a switching power supply is used. (It is important to note that the electrical system in Japan is 100 V ac at both 50 and 60 Hz.)

Manufacturers that want to market devices in Japan should consider that marketing goal in their design phase and incorporate flexibility into their design to meet the country's requirements. This gives them a better opportunity to have EN (European Union), NRTL (United States and Canada), and JIS testing done simultaneously. Although additional samples and time may be needed to complete the JIS testing, a third party that is accredited in all of the company's current and anticipated sales markets can minimize redundant tests whenever possible.

As mentioned, the revised PAL brought with it a requirement to manufacture under an audited quality management system, which ensures conformity with JGMP requirements. When a device manufacturer chooses a third party, it should also consider the location of the JGMP-qualified auditors and whether the JGMP audit can be combined with the quality management system audits required by the United States, Canada, and the European Union.

FDA's accredited persons inspection program audits to 21 CFR 820 requirements, but the program is only open to those companies that are not under FDA scrutiny (i.e., increased FDA attention owing to nonconformities, product recalls, etc.). Because low-risk device manufacturers are only periodically audited by FDA and these audits cost very little, the only incentive for FDA establishments to use a third party for inspections is the predictability of the audit.

The European Union allows an ISO 13485–based audit to meet Annex V requirements under the Medical Devices Directive and Annex IV under the In Vitro Diagnostic Directive. The Canadian Medical Devices Conformity Assessment System is strictly based on ISO 13485. Therefore, many manufacturers maintain an ISO 13485 registration with many clauses and elements similar to JGMP requirements. As a result, third parties that offer accreditations for all of these regulatory programs can offer integrated audits, which are less time-consuming, less intrusive, and potentially less costly to the manufacturer.

Other considerations the MAH should make in choosing a third party are experience, trust, and the MAH's relationship with the organization. Bear in mind that all applications for device licensing to a third party can only be made through the MAH located in Japan to the third-party certification body in Japan. However, the value of local support for foreign manufacturers is worth considering in understanding the requirements these manufacturers must meet.

The Goal of Alignment

As indicated, one of the goals of the revised PAL was to align Japan's medical device regulatory system with those of other advanced nations, namely those of the United States and the European Union. Because these nations produce and consume the majority of the world's medical devices, the regulatory practices in these regions are generally the ones accepted and adopted by device manufacturers worldwide. Just as with the regulatory systems from these regions, Japan's revised PAL allows third parties to conduct assessments of Class II medical devices for certification to market and sell in a particular region. Both EU and U.S. health authorities also require an audit of each manufacturing location to ensure that the quality system conforms to GMPs. The last similarity is the identification of an in-country representative—the MAH in Japan, the agent in the United States, and the authorized representative (AR) in the European Union. The biggest difference is that the MAH, as the name implies, takes over ownership and responsibility for certification, whereas the AR and the agent work on behalf of the manufacturer.


Although the revised PAL aligns more closely with general international requirements for medical devices, demonstrating conformance with the PAL still requires manufacturers to invest time and effort to understand its requirements. Once the regulatory process is defined, manufacturers must still contend with the challenges and cost of device-specific processes for reimbursement, distribution, and packaging. However, if the Japanese medical device market continues to grow and maintains its need for foreign medical devices, meeting PAL and MHLW requirements may be a worthwhile investment for device manufacturers.

Steve McRoberts is Underwriters Laboratories' (UL) global principal engineer for medical regulatory programs. Seiko Ohyama is a lead engineering associate working for UL-Japan Inc. Tara Kambeitz is the global marketing manager for UL's medical business unit. She can be reached at [email protected].

1. U.S. International Trade Commission, Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets, March 2007; available from Internet: http://hotdocs.usitc.gov/docs/pubs/332/pub3909.pdf.

Copyright ©2008 Medical Device & Diagnostic Industry

Wed, 18 Jan 2023 10:00:00 -0600 en text/html https://www.mddionline.com/news/understanding-japans-medical-device-certification-system
Killexams : Post-Baccalaureate Certificate, Pre-Medical

The Post Baccalaureate Pre-Medical Certificate is intended to give students who already possess a baccalaureate degree the opportunity to complete or Boost their performance in courses required to successfully apply to medical school. Each student will receive one-on-one advising on course selection to tailor the certificate to their individual needs. Along with coursework, this certificate program offers advising for MCAT prep, writing the personal statement, and other aspects needed to be a successful applicant. A committee letter is offered to students who complete the certificate and apply to medical school. The certificate requires 24 credits of coursework and should be completed in 12-24 months.

Required Courses (24 credits)

Choose from the following:

For additional information, contact Carol Myers, program coordinator.

Thu, 06 Oct 2022 04:04:00 -0500 en text/html https://www.uml.edu/catalog/undergraduate/post-baccalaureate-certificates/pre-medical-certificate.aspx
Killexams : How to Get a Medical Certificate Without Leaving Your Sick Bed
At Lifehacker, we independently select and write about stuff we love and think you'll like too. We have affiliate and advertising partnerships, which means we may collect a share of sales or other compensation from the links on this page. BTW - prices are accurate and items in stock at the time of posting.

One of the worst parts about getting sick is having to lug yourself to the doctor’s surgery just to get a medical certificate to send to your boss, when all you want to do is lay in bed. Well, we’re here to take some of that pain away by introducing you to Updoc.

Updoc is a trusted Aussie health platform that allows users to get legit online medical certificates or consult with doctors without having actually to go into a doctor’s surgery. Yep, that means you don’t even have to leave your bed.

How does Updoc work?

While it does sound too good to be true, it’s actually a super simple process. All you have to do is complete a quick consultation form with your health concerns/why you’re feeling awful, then an independent registered Aussie partner doctor will review the consultation. If approved, they will send a medical certificate directly to your inbox within a few hours.

Alternatively, if you need more of a general consult, you can now easily speak with a registered Health Practitioner about any health-related issues you need help with from anywhere in Australia. If required, they’ll get you sorted with a prescription or a referral or provide you with a medical certificate and send it immediately to your inbox.

Is using it expensive?

Surprisingly, it won’t cost you an arm and a leg, with consults for medical certificates starting from just $19.95. General consultations also start from $49.95.

What are the operating hours?

General consultations are available from 9am to 10pm on weekdays and 9am to 5pm on weekends, and can be accessed from anywhere in Australia. If you’re just after a standard medical certificate, you can submit a request at any time of day throughout the week, and Updoc will get to your request urgently within the next day.

Is Updoc legitimate?

All of Updoc’s certificates are valid documents and meet all the requirements of the Fair Work Act 2009 — which requires providing enough evidence that the employee was genuinely entitled to the sick or carer’s leave. Your employer is allowed to ask for more evidence if they require it, and employers can validate the authenticity of certificates through the “employer verify” section of Updoc’s website.

So long, waiting rooms. If you’d like to learn more about Updoc, you can head over to its website here.

Wed, 15 Feb 2023 03:30:00 -0600 en-AU text/html https://www.lifehacker.com.au/2023/02/doctors-certificate-quickly-updoc/
Killexams : The case for halal certification of medical devices

In a accurate article, we described how the new EU Medical Devices Regulation and revisions to ISO 10993-18, the international standard related to the chemical characterization of materials, were affecting the way in which medical manufacturers source and process polymers. There is another development underway in Indonesia and some other majority-Muslim countries that will also impact material selection, albeit through a different prism. A law in Indonesia stipulates that all imported, distributed and traded products, including medical devices, will need to be halal-certified by 2019, according to Jacqueline Anim, Principal Material Engineer and Subject Matter Expert at Ethicon (Cincinnati, OH), part of the Johnson & Johnson (JNJ) family of companies. 

Products that carry the Halal certificate have been processed according to rules established by the Islamic Council. Certification is mainly applied to meat and other food products such as milk, canned food and additives, but it can also apply to medical devices, as will be the case in Indonesia per Law no. 33, which was passed in October 2014. Until it goes into effect next year, compliance is voluntary.

Medical device OEMs and their suppliers need to have this on their radar, says Anim, because “the region is a potential growth area for the marketing and sale” of medical products. Manufacturers need to be able to answer questions such as, “Do you have animal-derived raw materials in your product?”  If the answer is yes, added Anim, the question then becomes, “Is the animal-derived raw material obtained in a manner that is consistent with halal certification or was it produced in a halal-certified manufacturing facility?”

The concept of halal applies to a wide range of goods and services used in a Muslim’s daily life, explains USA Halal Chamber of Commerce Inc. Muslim consumers choose products because it is in compliance with the process and procedure as defined by Islamic Law (Sharia). Industry and producers of goods and services are often not aware of these requirements. Subsequently, they overlook the needs of this segment of our population, according to USA Halal Chamber of Commerce.

Moving away from ingredients derived from traditional animal sources is a trend that transcends Muslim beliefs, added Anim, who will be discussing the evolution of medical materials during a conference session at PLASTEC/MD&M Minneapolis later this month.

During the session, Anim said that she hopes “to bring into focus the exponential advances that medical materials are making to integrate today’s medical solutions with future patient care.” That future, she stresses, will be animal free.

“Ingredients such as mold-release products and additives historically have been sourced from animal tallow, but they are now available from vegetable-based materials. Some of the material innovations that were not possible a decade ago are now feasible, as vendors such as Trinseo, for example, have switched to animal-free raw materials over concerns of bovine spongiform encephalopathy, commonly known as mad-cow disease. This is what is referred to as ‘kosher manufacturing’ practices. Technologies that do contain animal-based substances must undergo extensive scrutiny,” added Anim, more so than vegetable-based alternatives.

In that context, Indonesia’s halal law is one more brick in the wall of a larger trend. “As article 4 of the bill states, ‘products that enter, circulate and trade in the territory of Indonesia must be halal certified.’ If a provider of plastics or a medtech OEM has the intention of doing business in that region, he must comply with the law,” stresses Anim. “This means that raw materials and the manufacturing process must be backed by a Halal Assurance System (HAS) and the ‘halal’ or ‘non-halal’ certificate must be placed on the product in a noticeable and readable format that cannot be erased or removed. Other countries in the region that embrace halal certification include India, Bangladesh, the Philippines and Pakistan, to name just a few,” said Anim. Malaysia’s Department of Islamic Development is expected to introduce halal certification for medical devices—the first of its kind—later this year, according to Thomson Reuters.

Anim will discuss a range of issues related to trends and innovation in the medical materials space during the Technical Solutions conference track in room 211B at the co-located Medical Design & Manufacturing (MD&M) and PLASTEC Minneapolis event on Oct. 31 and Nov. 1. She is scheduled to speak at 8:30 AM on Oct. 31.

Mon, 13 Feb 2023 10:00:00 -0600 en text/html https://www.plasticstoday.com/medical/case-halal-certification-medical-devices
Killexams : LA city firefighters host regional search-and-rescue training at Disaster City

Thursday, Feb. 9 was the 52nd anniversary of the Sylmar Earthquake, which killed more than 60 people, heavily damaged Olive View Medical Center and Veterans Hospital, partially collapsed freeway interchanges, and caused the near-total failure of Lower Van Norman Dam, forcing thousands of people downstream to evacuate.

So it was timely that on Thursday the Los Angeles City Fire Department held a Regional Technical Search Specialist Course event at the department’s “Disaster City” built behind Fire Station 88 in Sherman Oaks. At Disaster City, urban search and rescue task forces from fire departments throughout the region “learned the latest search operations using specialized equipment,” said Captain Erik Scott, L.A. City Fire Department.

“It went very well,” Scott said of the training for a half-dozen urban search and rescue task forces who tried out  the simulated disaster zone. “It was a timely pre-planned training event that is very important in the light of the earthquake in Turkey and the 1971 quake in Sylmar.”

Four teams systematically searched the “disaster” area using specialized technical equipment such as snake-eye cameras that “you can put in the cracks in rubble … to look for people who might be in the rubble,” Scott said, and sensitive listening devices “that are magnetic and can be placed on walls to listen through them if someone is trapped inside.”

  • The Los Angeles City Fire Department (LAFD) Regional Technical Search...

    The Los Angeles City Fire Department (LAFD) Regional Technical Search Specialist Course, or “Disaster City,” brings regional disaster response Instructors and students together to practice and learn lifesaving search skills at the John Ruedy Memorial Training Center at Fire Station 88 in Sherman Oaks CA, Thursday, Feb 9. 2023. (Photo by Gene Blevins/Contributing Photographer)

  • The Los Angeles City Fire Department (LAFD) Regional Technical Search...

    The Los Angeles City Fire Department (LAFD) Regional Technical Search Specialist Course, or “Disaster City,” brings regional disaster response Instructors and students together to practice and learn lifesaving search skills at the John Ruedy Memorial Training Center at Fire Station 88 in Sherman Oaks CA, Thursday, Feb 9. 2023. (Photo by Gene Blevins/Contributing Photographer)

  • Java dog with CA-TF-1 sniffs for simulated victims at the...

    Java dog with CA-TF-1 sniffs for simulated victims at the Los Angeles City Fire Department (LAFD) Regional Technical Search Specialist Course at “Disaster City” behind LA City Fire Station 88 in Sherman Oaks CA, Thursday, Feb 9. 2023. (Photo by Gene Blevins/Contributing Photographer)

  • The Los Angeles City Fire Department (LAFD) Regional Technical Search...

    The Los Angeles City Fire Department (LAFD) Regional Technical Search Specialist Course, or “Disaster City,” brings regional disaster response Instructors and students together to practice and learn lifesaving search skills at the John Ruedy Memorial Training Center at Fire Station 88 in Sherman Oaks CA, Thursday, Feb 9. 2023. (Photo by Gene Blevins/Contributing Photographer)

  • The Los Angeles City Fire Department (LAFD) Regional Technical Search...

    The Los Angeles City Fire Department (LAFD) Regional Technical Search Specialist Course, or “Disaster City,” brings regional disaster response Instructors and students together to practice and learn lifesaving search skills at the John Ruedy Memorial Training Center at Fire Station 88 in Sherman Oaks CA, Thursday, Feb 9. 2023. (Photo by Gene Blevins/Contributing Photographer)

  • Los Angeles City Fire Battalion Chief Craig White(R) talks during...

    Los Angeles City Fire Battalion Chief Craig White(R) talks during press conference at the Search Specialist Course, or “Disaster City” at John Ruedy Memorial Training Center at Fire Station 88 in Sherman Oaks CA, Thursday, Feb 9. 2023. (Photo by Gene Blevins/Contributing Photographer)

To make it seem all too real, the teams could sometimes hear “a baby crying,” or “a person moaning from pain.”

The trainees used hand-held CPS to track their own movements, marking where the had already been so they could move on to areas not yet searched. “That information is sent back to the commanders in real time” where the incident commanders and decision-makers at Disaster City could update their strategic tactics, said Scott.

The recently renovated training site is formally known as the John Ruedy Memorial Training Center, and is a reminder, Scott noted, “that our firefighters are in a constant mode of training.”

Fri, 10 Feb 2023 03:11:00 -0600 Staff report en-US text/html https://www.ocregister.com/2023/02/10/la-city-firefighters-host-regional-search-and-rescue-training-at-disaster-city/
Killexams : Benefits of ISO 13485 Certification for Medical Device Manufacturing

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers achieve both those aims and others.

Parts of the ISO 13485 process involve identifying and documenting processes. For example, company representatives must find all processes that have even a minor connection to manufacturing. Next, they must create written procedures to establish which elements could introduce risks to the product.

Those threats could range from contaminated equipment to poorly trained personnel. After bringing attention to the risks, company representatives must name and describe measures to mitigate the potential issues.

ISO 13485 does not spell out the specific measures for device manufacturers to take. However, the certification gets people in the mindset that quality happens at every stage of manufacturing and that ongoing efforts enable maintaining high standards.

Reducing the Likelihood of Longstanding Issues

Another component of ISO 13485 requires ongoing managerial reviews to determine whether previously implemented controls work as expected or if further tweaks would get better results. Unfortunately, some leaders see these evaluations as box-checking exercises and feel under excessive pressure to get them done.

However, gathering relevant data and creating processes to keep that information up-to-date and accessible can make it easier to carry out thorough, non-rushed reviews related to ISO 13485. 

For example, looking at customer feedback, audit results, new regulatory requirements, and any details of corrective actions taken so far can help decision-makers verify whether quality controls related to ISO 13485 have the desired effects.

Additionally, these periodic reviews Boost the chances of catching issues that could lead to faulty products or operational efficiencies. They encourage better visibility that limits the likelihood of an unaddressed issue causing long-term problems.

Increasing Marketplace Competitiveness

The most accurate version of ISO 13485 requires that certified companies insist that any subcontractors conform to the standard, too. That means the commitment to quality extends beyond a particular organization. Many potential customers appreciate that, knowing that working with any new company poses challenges. ISO 13485 reduces many of them with its emphasis on quality.

Also, since ISO 13485 is an internationally recognized standard, it can help in cases where company leaders want to expand into other countries and boost their chances of success. Certification assists organizational leaders in conveying that they take quality seriously.

It’s vital to convince stakeholders of efforts to prioritize quality since medical devices directly affect people’s lives. Minimizing the chances of harm and increasing positive outcomes helps potential customers build trust in a company and decide it makes sense to work with or purchase from them.

Helping Products Stay on the Market Without Issues

Statistics indicate that approximately 4,500 medical devices and drugs get taken off the market owing to recalls. Just as managerial reviews of ISO 13485 processes can prevent persistent issues, a certified company is less likely to experience problems that lead to getting products pulled from shelves. In addition to the lost profits that such events cause, recalls can permanently damage the public’s reputation, making many people perceive a troubled brand as unsafe.

However, corrective and preventive actions get built into the ISO 13485 framework, helping company representatives identify and tackle problems faster than they otherwise might. It’s also advantageous that getting certified can help create and maintain a culture of personal responsibility within the organization.

Once an employee understands that a single missed step or ignored protocol could cause quality issues that affect a whole organization, they’ll likely become more conscious of their behaviors and choices made while working.

Plus, if a company does experience a recall, being ISO 13485-certified should make it easier to target where things went wrong and prevent future issues. Doing those things should bolster public trust and reassure people that a device manufacturer has its operations under control.

ISO 13485 Certifications Strengthens Medical Device Companies

The medical device sector is a high-pressure industry where people praise innovation as long as it doesn’t sacrifice user safety. Moreover, manufacturers must respond to demand spikes, as instances like the surge in ventilator needs during the COVID-19 pandemic showed.

Getting an ISO 13485 certification can help a company make positive, permanent quality and process improvements. Thus, representatives from certified companies often find that ISO 13485 contributes to organizational resilience. It’s not right for every organization, but the associated benefits make it well worth consideration.

Sun, 12 Feb 2023 10:01:00 -0600 en text/html https://www.plasticstoday.com/medical/benefits-iso-13485-certification-medical-device-manufacturing
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