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IMDRF final document: Software as a Medical Device (SaMD): Application of Quality Management System

The IMDRF published in October 2015 the guidance document titled "Software as a Medical Device (SaMD): Application of Quality Management System" in its final version.

The draft version was published in March 2015. The draft version was opened to comments through a public consultation made by the IMDRF between March and May 2015.
The final version was updated after analyzing the comments from the public consultation.

IMDRF and MDSAP

IMDRF's job is not on software medical devices only. It has several working groups, including one working on the Medical Devices Single Audit Program (MDSAP). The mission of the MDSAP working group is to define an audit scheme applicable to several regulations (see IMDRF website, that's not simple :-).
Canada is in terms of reactivity the country which takes the MDSAP the most seriously. By 2017, Canada will accept MDSAP certificates to get the clearance of medical devices. And by 2019, Canada will accept MDSAP certificates ONLY. This is what they announced early December 2015.

What to do with this document?

This IMDRF document claims that it is not intended to replace existing regulations and standards. For sure, the IMDRF can't do that, this is not their field of action.
But,
Given that:

  • This document is one of the rare guidances on QMS for standalone software medical devices,
  • IMDRF's mission is to develop the MDSAP,
  • Auditors are keen at looking at guidances, to issue remarks laid on solid foundations,
  • Auditors also like when manufacturers define the provisions of their QMS based on relevant guidances,
  • MDSAP auditors will know the existence of IMDRF documents,

This document may acquire a reputation, and even notoriety.

This is just speculating. But such document requires a lot of work. I bet it won't be left apart.



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