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FDA 21 CFR Part 820 vs ISO 13485

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Guest user Created:   Feb 12, 2018 Last commented:   Feb 12, 2018

FDA 21 CFR Part 820 vs ISO 13485

I am in charge of implementing FDA 21 CFR Part 820 for my company. We may also be selling our product in Europe in the future. Would complying with ISO 13485:2016 meet all FDA QSR requirements?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Feb 12, 2018

Answer:

They have several differences, which is what have kept them from harmonizing. ISO 13485 is a standard based on ISO 9001 that is specific to medical devices. This standard is not adopted by the Food and Drug Administration (FDA) but the FDA participated in writing ISO 13485 to make sure their requirements and ISO 13485 are aligned. The FDA QSR has more stringent complaint handling & reporting requirements

However, if a company meets the requirements of ISO 13485:2003, they should easily be able to meet the FDA Quality System Requirements (QSR).

For more information, see: Differences and similarities between FDA 21 CFR Part 820 and ISO 13485 https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/
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Feb 12, 2018

Feb 12, 2018