Additional requirement to ISO13485 that has to be addressed for MDSAP
My question is about MDSAP. I like to know what additional requirement to ISO13485 hqs to be addressed for MDSAP.
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The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
MDSAP is based on ISO 9001:2015 so the following aspects are not covered in the ISO 13485:2016:
- Context of the manufacturer
- Interested parties
- Business risk assessment
What are more differences between ISO 9001:2015 and ISO 13485:2016 you can see on the following link:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
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Apr 02, 2021