Guest user Created: Oct 15, 2018 Last commented: Oct 15, 2018

Compliance of QMS and FDA 820

Just learning about different Quality Management Systems in college. I'm wondering if an Irish Company wants to sell medical devices into USA, is it enough for them to implement ISO 13485, or would they have to implement FDA 820 as well? Can a company have more than one QMS?

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Verlene Law Oct 15, 2018

Answer :

It is sufficient to have just a single set of Quality Management System in place to meet the different regulatory requirements. Any devices intended for import into the States has to comply with the requirements of FDA 820 depending on the classification and registration route of the device.

For more information, please refer to :

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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Oct 15, 2018

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