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Additional requirement to ISO13485 that has to be addressed for MDSAP

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Guest user Created:   Mar 31, 2021 Last commented:   Apr 02, 2021

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Apr 02, 2021

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:

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Mar 31, 2021

Apr 02, 2021