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Declaring compliance without certificate

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Guest user Created:   Mar 20, 2018 Last commented:   Mar 20, 2018

Declaring compliance without certificate

Hi Strahinja,
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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 Mar 20, 2018
Working on a contract to distribute MRI's in the US for a 13485 certified overseas manufacturer. While specific metrics will serve best, wondering if adding "Manufacturer agrees to fulfill the minimum standards outlined in ISO 13485 regarding replacement parts, remote support and on -site service" will provide added protection? As you know, competitors and customers in the US are pretty demanding.

Answer:

The statement itself doesn't change much in this situation. If the manufacturer has ISO 13485 certificate, then you are OK, although the customers can even require you as a distributor to have the certificate. If you are performing some activities other than distribution (e.g. servicing, installation, etc.), the customers would certainly require you to obtain ISO 13485 certificate. The good news are that the implementation wouldn't be that hard and the certification would not cost too much.

For more information on the ISO 13485 implementation process, see: Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
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Mar 20, 2018

Mar 20, 2018

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