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.

Free Quote - Get Started Today

Enter your details below to get started on your journey to certification.

Get Started

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.

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 15385 certification?
Contact PJR today at (248) 422-3013 or send a request to pjr@pjr.com to get your certification started!

Get a Free Quote

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.

PJR Resources

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.

Supplier Audits

What Our Clients Say

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!

Nouredin Albanghazi

I am writing to express my gratitude for the professional attitude PJR demonstrated throughout our recent audit. It has been a pleasure working with you, and I am genuinely impressed by your expertise and dedication. Your thorough approach and attention to detail were invaluable, and it’s clear that you are a true asset to our industry. Your ability to handle the audit process with such professionalism and efficiency made a significant difference, and I wanted to acknowledge your hard work and commitment. It’s not often that one encounters such a high level of proficiency and integrity in our field, and it was truly a pleasure to collaborate with someone of your caliber. Thank you once again for your exceptional service and professionalism!

Michael Payne

To our Project Manager and office staff, thanks for making the process happen so quickly and taking the lead on a challenging situation. To our Auditor, great job overall. You’re great to work with and we look forward to having you back in Arkansas next year. Let me know if you need anything further, otherwise we will look forward to the final report and our new PJR supplied certificate.

Anthony Lawenko

We switched from a particular registrar to Perry Johnson Registrars when I was an employee at George B. Woodcock & Co. and now that our company has been acquired by Custom Packaging Supply Inc., we chose to continue with PJR as our registrar because the service they provide is outstanding. So many people that I have corresponded with or worked with and each of them represents PJR to the highest standards. Everyone is cordial and professional. We look forward in continuing to do business with PJR.

Jos van der Linden

ISO certification is an important part of our operational strategy, and PJR was a great audit partner to make it a reality. Thank you for helping us efficiently and rapidly.

Ryan Bratz

PJR was very helpful in making our audits during COVID-19 possible. The Virtual Audit process was smooth and went well. Thank you for the equipment to make this possible.

Ken Selover

PJR did an excellent job of explaining the certification process and helping us along from start to finish.

Terri Woosley

I have nothing but good things to say about the personnel at PJR. Everyone was extremely helpful in answering questions and getting back to us in a timely manner. I would recommend PJR to anyone going through ISO 9001 audits.

Dan Gonsalves

It’s not often that I give out five-star reviews, but PJR really deserves it. From my first call with the sales department, to scheduling and ultimately the actual audit and every point of contact in-between, PJR rocks!

Mark Hahne

PJR conducts audits very professionally with very highly-trained auditors. I would recommend PJR to anyone seeking a registrar that will give you a fair assessment and provide valuable feedback to your organization.

Gerald W. Bennett

Our auditor is always a pleasure to work with. I feel as though my understanding of ISO standards has been greatly enhanced through working with her. Temperament is key in these things, and our auditor is geared toward the success of the audit. Very tough, but very fair. This enables us to have a stronger system in place as a result.

Patrick News

PJR was flexible with the contract changes proposed by our legal team. Communications regarding the quote and assessment criteria and scheduling dates were thoroughly explained.

Roberto Segovia III

Our auditor was great and their professionalism was outstanding – a great audit experience!

Haley Lingerfelt

Our dedicated scheduler has been great to work with. She’s always friendly, professional, and willing to go the extra mile to ensure any inquiries have been addressed.

Brett Saburn

Thank you everyone for helping us get through our first AS audit. I appreciate your efforts in helping us expedite a tight timeline.

Carlos Parra

I wanted to reach out and express how happy and delighted I am with your team members that helped me to set up and schedule my Stage 1 and Stage 2 audits! I switched to PJR a few months ago and am appalled at the difference in customer service that your team has been able to provide. Thank you so much for making this certification process an easy and non-stressful one!

Aaron Wallace

Thank you and all of those on your team for all your hard work and dedication. It was a stressful year for everyone and I know you were all working around the clock to finish everything up on time. Please pass my thanks onto your technical review team as well for all their work!

Tanner McCarron

Thank you for your excellent service and care during the quoting process with Boon Logic. We received quotes from a few other vendors all of which approached us with the same approach: distant, not caring, and unconnected. It meant everything to me that you took the time to speak with me on the phone, learn about what we do as a business, help modify our Scope statement, and then have another follow up call to walk through pricing. It was because of this service that we chose to go with PJR. The decision was a very easy one. Getting ISO certified is a scary process. Your service towards us helped make the process a little less stressful and scary.

Chris Scantlin

I want to thank everyone at PJR for your expertise and professionalism in adapting to the changes all industries have been facing with the unforeseen implementation of COVID-19 in worldwide industries. I commend PJR on the virtual audit that took place, and how smoothly it was conducted. I can’t recommend PJR enough for their professionalism and willingness to help and adapt!

Bob Bitterman

Thank you so much to the PJR Team. We appreciate everything everyone has done to make us better to serve our customers.

Michael NedBal

PJR has excellent customer service and it has been a pleasure to do business with them.

Candace Hammond

We are so pleased with PJR and the quality of their services. Extremely happy and satisfied with the staff and their promptness when responding to any questions or concerns we have. Their communication with us is always timely and precise.

Belinda Millener

Working with Perry Johnson Registrars was a great experience. Everyone was very knowledgeable and helpful. They went above and beyond our expectations. We would highly recommend their services to any company pursuing ISO certification.

Steve Burlingame

We have enjoyed working with Perry Johnson Registrars. We feel as if PJR is a true partner with our organization and a valuable resource. We appreciate the online webinars and support your company provides.

Joanne Robinson

I have enjoyed working with the Perry Johnson Registrars team. The staff overall is phenomenal. I also enjoy the webinars. Thanks!

Bruce Klotz

I started working with the ISO 9001:1987 standard early in my career and have experienced the Standard evolve in my professional path. Over the years, I have worked with a number of Registrar organizations. This recent Audit was my first with Perry Johnson Registrars and I must say that you rank at the top of the List!

Steve Wynn

Everyone at Perry Johnson Registrars, Inc. has been great to work with. A truly World Class company!

Linda Aylward

Very pleasant and professional team. Very much enjoy working with PJR!

Paul Webber

PJR made the audit process simple and cost effective.

Horacio LaMadrid

We have approximately 20 years working with PJR and in all this time they have maintained excellent service.

Seth Callison

All the members of Baron Investigative Group appreciate the level of professionalism and service of PJR.

Anita Spaulding

PJR has been our registrar for many years!

Kelly Boyce

We have been very pleased since we switched to PJR in 2014 and would recommend your services to other companies.

Keith Rayburn

I would certainly recommend PJR to other companies.

Russell Kam

I am very happy with the levels of expertise, communication and customer service provided by PJR.

Lynette Brocht

We have been very satisfied with PJR, your auditors and the assistance you offer to us via your scheduling personnel, website and the webinars you offer.

Edward M. Janes

We are glad to be working with PJR and look forward to using your firm as a development resource for the new standard.

Carolina Roa

I would like to thank PJR on behalf of LUBLINE. We are very proud of our certification and will display the plaque in our conference room. We hope our business can continue to work together.

Win Everett

PJR has provided AGTeck with quality, timely service and support.

Ken Zintel

We have been very happy with the services provided by PJR!

Scott Blank

We have been blessed by the auditors which we have encountered since utilizing PJR in July 2015!

Raul Castro

WE TRULY APPRECIATE YOU GUYS!

Terry Williams

Our registration process has been a lot smoother than we ever expected!

Kevin Waldrip

PJR makes for a smooth audit and if I ever need to contact anyone it has always been a pleasure.

Tom Peterson

It was a pleasure working with Perry Johnson Registrars as always!

Bud Salsbury

PJR personnel have always been respectful, helpful and courteous. A very professional team!

Xiao Chan

It was a great experience working with PJR. Everyone was very helpful!

Betty Muldowney

PJR representatives are always responsive and professional!

John Kneeland Jr.

We have been very pleased with the assistance, feedback and follow up provided by all PJR employees and auditors.

Randy Haak

It is a joy to work with a company that takes pride in what they do.

Kelley Weitkemper

Always a pleasure working with all PJR employees.

Jeff Perlowin

Overall, a very positive experience. Thank you.

Kali Dietz

Another year of fantastic service!

Merzo Ramic

Years of doing business together is the best feedback one can get. Thank you all at PJR.

Roger Wahl

Knowing that ISO 9001:2015 isn’t supposed to have a final release until fall of this year, I expected the “Preparing for a Successful Transition” webinar to be filled with expectational fluff. I was pleasantly surprised to actually learn a number of different things that will be of some use to me while maintaining my company’s QMS. The presentation was well laid out and the presenter reflected a sound knowledge of the topic. I have viewed several PJR webinars and I haven’t been disappointed yet. Even considering they are “free”, I have felt cheated by paying for other webinars that fell way short of expectations. Keep up the good work!

Scott Chambers

Everyone at PJR is a pleasure to work with. No Complaints.

Marie Raubeson

DITF is very satisfied with PJR as our registrar and will continue to contract services in the future.

Mary Thiessen

It has always been a pleasure to work with PJR. We are very happy with this business relationship and plan to continue our registration process with them in the future.

Kinney E. Hardin

It was a true pleasure to work with you folks. With all my dealings with PJR, you were candid, straight forward & fair. This was my first ISO 13485 Audit and our auditor was patient, thoughtful & kind. Everybody at PJR very helpful and mindful of IPB’s desires and objectives. Always encouraging and offering resources for training & guidance. IPB is firmly on our way to the top with an Effective Quality Management System. I’m excited with the addition of PJR becoming part of the Future IPB Success story.

Rod Harris

Is, Was, and Has always been a pleasure working with PJR

Bryan Barnett

We have used PJR since the very beginning of our ISO system and have always been very pleased with the service we receive.

Brooke Miller

We have worked with PJR for several years. Everyone we have worked with has been very professional and a pleasure to work with.

Dan Hill

We are very satisfied with the professionalism that PJR exhibits continually each time we are in contact.

Rodney Allen

It is truly a pleasure doing business with PJR. Class-act all the way.

Kurt Puleo

Perry Johnson Registrars has always been excellent to work with over the past 8 years.

Rocco Palmer

PJR is a very professional organization.

Gary McDonald

Your office staff and auditors are great to work with and are very helpful.

John Kneeland Jr.

We are very comfortable working with PJR and would recommend them to anyone looking to become ISO certified.

Peter Hladun

Overall I am very happy with PJR as an auditing firm and look forward to continuing our business.

Terry O. Brooks

We feel that PJR is a wonderful organization to work with!

Garth Davies

PJR’s guidance and constant supply of information eliminated all guess work and insecurity for Enameled Steel.

Paul Becker

We have been very satisfied with PJR, exceptional the auditors we have had. Customer Service has been wonderful.

Kenneth Moore

We are pleased with all aspects of Perry Johnson Registrars. Thank you.

Lisa Wendling

As always, it was a pleasant, informative and constructive audit. We look forward to working with PJR again.

David Landis

Process for obtaining and maintaining certification is simple and trouble free.

Benjamin Yoder

The PJR auditors were very polished and professional. DTI is quite happy with their performance and feel they give the kind of customer support and satisfaction we’re looking for. Their thoroughness, as well as experience, provided DTI with a confident feeling that will continue to improve on the already solid QMS system in place. We look forward to our working relationship with PJR and their team.

Art Pecaut

I would like to take this opportunity to express our appreciation for the timely manner our AS9100 audit request was handled on such short notice. Thanks to our audit coordinator for a job well done.

David Zedaker

I am impressed with all of the PJR employees that I have had contact with in the past several months, especially our PJR Lead Auditor.

Greg Finch

Surveillance audit went great. The auditors PJR sent were excellent. The most positive and educational audit that we have been through.

Priscilla Paclik

Our company has been very pleased with your process. The PJR auditor is very informative in explaining a non-compliance issue as well as positive aspects of our processes.

CW2 William Greensmith

Auditors have been very professional and knowledgeable. Customer service has also been very convenient and courteous.

David McCoy

The audit team that was sent was extraordinary. Their experience in the industry and knowledge of AS9100 requirements was exceptional. I have had a lot of experience both as an auditor and being audited and I can honestly say that this was THE best audit team I have ever worked with.

V. Raj Narayanan

PJR auditor was very professional and easy to work with. I look forward to working with him in the near future.

Arvind Sitapara

Entire process is very satisfactory.

Jim Young

Believe me, I realize it looks disingenuous to give 5’s (excellent) in all categories; however, I have never experienced anything but excellent service from Perry Johnson’s Home office, the Dallas office, and the auditor. Our auditor is very helpful with guidance for making improvements, but still very fair and very firm.

James Kolasinski

Our auditor arrived promptly on schedule and conducted the audit in a professional manner. Thanks PJR!

Danny Gesell

Very satisfied with the services of PJR.

Jason Conover

We are very satisfied with PJR.

George Hoover

Everyone is very professional and reliable.

Ronald E. Mullinax

We continue to receive excellent service with the PJR team. The personnel that we deal with are professional and understand what ‘Customer Service’ means. We appreciate your service and assistance at our site. We anticipate working with your firm for an extended period of time.

James Bierman

Our auditor demonstrated excellent knowledge of the ISO standard. He was very professional and took time to explain all aspects of the audit.

Jackie Perry

I am happy to say the people at PJR I have met and have talked to have been very professional. They respond very quickly to our questions and concerns. We are extremely happy that we chose a registrar that has excellent employees working for them and their customers.

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.