Is there a standard equivalent to automotive standard AEC-Q200 for the medical sector?

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Asked 2 years, 4 months ago

Modified 2 years, 4 months ago

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I want to ensure components of high integrity characteristics are utilised in a design by a third party.

In the automotive sector AEC-Q200 can be stipulated, e.g. (https://www.digikey.com/en/product-highlight/p/panasonic/automotive). Is there any similar standard that can be stipulated for medical products?

asked Jan 6, 2021 at 12:24

SeanJ

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\$\begingroup\$ AEC-Q200 is about stress tested components in cars; but medical device components have potential to harm patients. There is a quality standard applicable to the device manufacturer and their component suppliers, ISO/CD 13485. This standard is now used by the USA Food and Drug Administration. You may perhaps want to specify "clinical grade" components from an ISO 13485:2016 certified supplier. \$\endgroup\$
– MarkU
Jan 6, 2021 at 21:20
\$\begingroup\$ I see you're based in Ireland; in USA the FDA requires Establishment Registration and U.S. Agent to be able to sell a medical device in the USA. Europe may have analagous registration requirements for anyone selling medical devices, even if designed by a third party. \$\endgroup\$
– MarkU
Jan 6, 2021 at 21:23
\$\begingroup\$ @MarkU afaik iso 13485 is not necessary for component suppliers. It refers to the quality around the product. Try find a full set of components that were on manufactured in compliance with iso13485 for a product design... \$\endgroup\$
– SeanJ
Mar 8 at 0:23

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