ISO 13485

Medical Devices Quality Management System

ISO 13485 is the internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It demonstrates an organization's ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

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ISO 13485:2016 – The Global Benchmark for Medical Device Quality

ISO 13485 - Medical Devices

ISO 13485 is a sector-specific quality standard for the medical device industry. The standard’s full name is
ISO 13485, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

In an industry where consumer health and safety are paramount, ISO 13485:2016 stands as the essential sector-specific standard for medical device quality management systems (QMS). Whether you are a small startup or a multinational corporation, achieving certification demonstrates a world-class commitment to the design, manufacture, and distribution of safe, effective medical devices.

The New Era: ISO 13485 and the FDA QMSR

The most significant update in decades for the U.S. medical device market is the FDA’s transition to the Quality Management System Regulation (QMSR).

Alignment with Global Standards: As of February 2, 2024, the FDA published a final rule that incorporates ISO 13485:2016 by reference, largely replacing the older 21 CFR Part 820 (QSR).
Implementation Deadline: By February 2, 2026, all manufacturers selling devices in the U.S. must comply with the QMSR, which mirrors the requirements of ISO 13485.
Philosophy Shift: The FDA is moving away from checklist-oriented inspections toward a process-based, risk-based approach that follows the entire product life cycle.
PJR Expertise: With the FDA harmonizing its requirements with international standards, PJR’s decades of experience in ISO 13485 certification provide a direct pathway for U.S. manufacturers to meet these new regulatory expectations seamlessly.

Recent Updates: The 2024 Climate Action Amendment

As part of a global initiative, ISO published ISO 13485:2016/Amd 1:2024, which introduces new climate-related considerations into the management system:

Clause 4.1 Addition: Organizations are now required to determine if climate change is a relevant issue to their QMS.
Interested Parties: Understanding the needs of stakeholders now includes considering requirements related to climate change.
Impact: While this does not require a new certificate, certified organizations must demonstrate during their next audit that they have assessed climate change risks as part of their organizational context.

Why Pursue ISO 13485 Certification?

Certification is more than a badge; it is a strategic business tool that facilitates compliance with global regulators and customer expectations.

Global Market Access: ISO 13485 is often a prerequisite for international expansion and is the baseline for many country-specific requirements.
Operational Efficiency: The standard outlines how to review and improve processes, helping to cut costs and monitor supply chain performance.
Enhanced Credibility: Certification simplifies the sales process by providing immediate evidence of your quality system’s efficacy to prospective clients.

Integrated Safety: Cybersecurity and ISO 27001

As medical devices become increasingly connected, they face growing cybersecurity threats that can compromise patient safety and hospital networks.

Total Compliance: To complement your ISO 13485 QMS, PJR offers certification to ISO 27001 for Information Security.
Protecting Data: This integration ensures that your electronic medical devices are not only safe for clinical use but also secure against data breaches and insurance fraud, protecting patient safety and healthcare networks.

The PJR Advantage: Your Partner in Excellence

Choosing Perry Johnson Registrars means partnering with a leader in the certification industry. We provide a clear, supportive path to certification through:

ANAB

Process Performance Auditing (PPA): Our unique method moves beyond checklists to focus on how your processes drive improvement.
Experienced Technical Team: Our auditors average 15 years of experience in the quality industry, ensuring your audit is a value-added experience rather than just a compliance check.
Global Recognition: PJR is accredited by ANAB to register companies to ISO 13485, ensuring your certificate is respected worldwide.

Additional Information:

Ready to start your journey to ISO 13485 certification?
Contact PJR today at (248) 422-3013 or send a request to pjr@pjr.com to get your certification started!

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Get Your Certification Issued in 4 Easy Steps

Partnering with Perry Johnson Registrars (PJR) means a clear, supportive path from preparation to certification and beyond. Our process is designed to make achieving and maintaining certification simple, efficient, and rewarding.

Application & Optional Pre-Assessment

Begin your certification journey by submitting an application and receiving a tailored proposal from PJR. Some clients may also request an optional pre-assessment or readiness review to evaluate preparedness before the official audit. This step helps identify potential gaps early, improving the likelihood of a successful certification.

Why Choose PJR as Your Certification Partner

Our team of experts are with you every step of your certification journey.

Fully accredited and globally recognized - PJR is accredited by leading bodies including ANAB, UKAS, JAB, and ACCREDIA, ensuring your certification is respected worldwide.
Value-driven auditing approach - Our Process Performance Auditing (PPA) method goes beyond checklists, focusing on how your processes perform and drive continual improvement.
Industry-experienced auditors - Our auditors understand your industry’s unique needs and provide meaningful insights that add real value.
Personalized, human service - When you call PJR, you speak with real people…not automated systems. You will always have personalized service from our dedicated scheduling team, ensuring quick, reliability, and thoughtful support throughout your certification journey.
Global reach with a local touch - Whether you are a small business or a multinational organization, PJR offers efficient, flexible service tailored to your size, scope, and location.

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Expertise for Every Industry

Here at Perry Johnson Registrars, we have the authority to grant certification to a wide range of international standards.

Please select a standard below to learn more, or browse all standards we certify.

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What Our Clients Say

David Hilton

Rocket Air Supply has had a very positive experience working with Perry Johnson Registrars. Their team has been professional, responsive, and helpful throughout the certification and audit process. We appreciate their clear communication, organized approach, and willingness to answer questions when needed. The level of service provided has helped make the process smoother and more manageable for our team, and we value the continued support from PJR.

Clifton Snodgrass

PJR has exhibited a level of support and professionalism not readily found in the business world of today. While we strive for excellence as an organization, we have our hiccups which PJR patiently supported and guided us through. We’ve had to move our schedule more than once and they accommodated with zero attitude or pushback. Quality and support 100% that is greatly appreciated.

Kris Dill

This is a painful process (the audit itself), but working with the PJR team makes the administrative side smooth. I appreciate the assistance and communication.

Robert Symczak (Zak)

Perry Johnson Registrars, Inc. is an Outstanding Organization with very knowledgeable professionals who are experts in the ISO arena. In my experience, PJR operates at an exceptional level within the ISO arena. Their structured methodology and deep understanding of ISO standards consistently support successful certification and long-term compliance.

Scott Chambers

Working with our auditor on our ISO 13485:2016 recertification audit was, as always, a pleasure due to her professionalism and expertise, and we eagerly anticipate collaborating with her again next year. After 20 years of partnership with Perry Johnson Registrars, we have consistently been satisfied and look forward to continuing our collaboration.

Lance Norris

Always professional and thorough!

Keith Marshall

In my eyes there is NO Better Registrar….than PJR. I have personally converted 4 separate Companies from other Registrars to PJR as PJR is a Top-Notch Registrar, FAR SUPERIOR to any other Registrars on the Market, as there is NO Better Registrar. I have personally NEVER had a Bad Experience dealing with PJR consisting of over 10 Audits for ISO 9001, ISO 13485 and AS9100 thru my years in Quality as a Quality Director or Quality Manager/Quality Management Representative. My opinion is comprised from the beginning to the end and receiving Certifications. All PJR Staffing could not be more Pleasurable to work with.

John D. Judd

Working with Perry Johnson has been nothing short of exceptional. Their professionalism consistently shines as the gold standard among all Registrars I’ve collaborated with throughout my 25-year journey in the Quality field.

Darrin Vickers

We wrapped up our audit yesterday with our auditor. Nothing but good things to say. He is very thorough, and my management team is very pleased with the performance and professionality of PJR!

Barrett Jenkins

I’ve managed manufacturing facilities in a lot of places all over the world, each of which have had to have some form of 3rd party business systems validation/registration. I’ve been beyond impressed with the Perry Johnson process. You all have been very easy to work with, and the quality of your audits are top notch. It’s important that our company is able to identify nonconformances in our systems if they exist, and I felt like our auditor did a very thorough, effective job in that effort. Again, many thanks for your assistance with this achievement and I look forward to continuing to work with PJR into the future!

PJR has been an accredited registrar since 1994; formal accreditation came in January 1995 by ANSI/ANAB.

Perry Johnson Registrars, Inc. has been accredited by seven different international bodies, is recognized by IAOB, and has an audit staff of over 500 auditors, averaging 15 years of auditing experience and 18 years of experience in the quality industry.

PJR auditors boast an average of 15 years of auditing experience and an average 18 years of experience in quality assurance. Auditors undergo a thorough qualifications process, which includes not only interviews, background checks, and references, but mandatory training modules, technical competency exams, observation and supervision audits, and annual auditor training.