
ISO 13485
Medical Device Quality Management Systems
ISO 13485 is an internationally recognized quality management system standard specifically for medical device manufacturers and related organizations. It outlines requirements to ensure consistent design, production, and delivery of safe and effective medical devices while meeting regulatory and customer expectations.
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ISO 13485

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.
Medical devices come in close contact with patients and range from minor support for medical conditions to lifesaving capability. As such, they demand high criteria. Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Registration to ISO 13485 requires accountability, compliance with regulations such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation, and traceability of products.
PJR is accredited by ANAB to register companies to ISO 13485.
- What is ISO 13485?
- Why do you need to get ISO 13485 Certified?
- Cyber Security for Electronic Medical Devices
- PJR offers Virtual Pre-assessments
For more information on ISO 13485, contact PJR today at (248) 358-3388 or send a request to pjr@pjr.com for a Project Manager in your area!
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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Here at Perry Johnson Registrars, we have the authority to grant certification to a wide range of international standards.
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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.
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