What is ISO 13485?
ISO 13485 sets out the requirements for a quality management system for organizations involved with medical devices, including design and development, production, installation and servicing. It also applies to suppliers and service providers that support those organizations.
What is the current edition of ISO 13485?
ISO 13485:2016, published in March 2016.
How is ISO 13485 different from ISO 9001?
ISO 9001 applies to every industry. ISO 13485 is written for the regulated medical device sector and puts more weight on regulatory requirements, risk management in product realization, process validation, documented procedures and traceability, and complaint handling and reporting to regulators. It does not use the Harmonized Structure of ISO 9001, ISO 14001 and ISO 45001.
Is ISO 13485 required to sell medical devices in Canada?
For Class II, III and IV devices, yes. A licence application under the Medical Devices Regulations must include a quality management system certificate to CAN/CSA-ISO 13485, issued under MDSAP by an auditing organization recognized by Health Canada. Class I devices do not need one.
Does the FDA require ISO 13485 certification?
No. FDA does not require or issue certificates, but since February 2, 2026 its Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference, so a Part 820 quality system is built on ISO 13485.
Who should consider ISO 13485?
Medical device manufacturers and specification developers; contract manufacturers and component and material suppliers; sterilization, calibration, servicing and distribution providers; and companies that need a Canadian licence for Class II, III or IV devices.
ISO 13485 at Paradygm
ISO 13485 is the medical device quality management system standard for manufacturers and their suppliers. See our ISO 13485 consulting page for how we coach gap assessment through certification readiness.
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