December 20, 2020

ISO 13485


ISO13485 is an international quality standard specific to the manufacture of medical devices. It is the medically focused version of ISO9001, expanding on what ISO9001 offers and providing confidence in our ability to meet a medical device’s regulatory requirements. There are plans for the FDA for a proposed rule revision of 21 CFR 820 (The FDA standard for medical devices) to harmonize with ISO13485 in the next 2-4 years.

Medical device manufacturers want to be sure that any partners they engage with to get their product to market will be able to support them in regulatory matters. If there is a problem, they need to be confident that their supplier (manufacturer) has the correct systems and records to be able to answer any questions from a regulator. It’s about having a partner you can trust.

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