Regulatory Globe|2 December 2020

MDSAP vs ISO 13485:2016 Checklist

The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase.

The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase. (Based on the MDSAP Companion document / FDA).

Benefits:

Simple overview / No paper chaos
Easy to sort by specific county requirements
The checklist supports well during the implementation
Helpful overview during the next MDSAP audit

What you get:

Instruction for use
Technical Support
Customer feedback improved tool

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EU-Authorised Representative

For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced...

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MDSAP vs ISO 13485:2016 Checklist

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EU-Authorised Representative

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