Software in Medical Devices, by MD101 Consulting

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

The International Medical Device Regulators Forum opened a consultation on a draft document about the application of Quality Management System for Software as a Medical Device (SaMD).
The consultation was opened in march and will be closed the 1st of June.

The document can be downloaded on the IMDRF website.


This document is not a revolution in SaMD world. It gathers the state-of-the-art in the organization and the management of software lifecycle processes.
It was not the case with the document named: Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls (sorry, I hadn't have time to write a post on that one, it's the first time I write about it). Hence it defines four categories for SaMD, where standards and regulations in place define three levels (security class of IEC 62034 and level of concern in FDA guidances).

ISO 13485 in watermark

The most interesting thing in this document is the way the application of a quality system management is presented. The structure of chapters (see the table of contents) and the concepts presented throughout the document are in line with those found in ISO 13485 standard.
There is even a matrix of correspondance with ISO 13485 at the end of the document.

ISO 13485 vs regulations

Bearing in mind that this document was written by medical device regulators, including US FDA, it's another proof of the convergence of regulators towards the use of ISO 13485 as a keystone to compliance.

What to do with it

Read it and don't do anything else on the spot. Take time to digest it. As I wrote above, this document gathers state-of-the-art good practices. It doesn't change the rules and the daily life of people dealing with compliance of SaMD to regulations.
At most, it's a set of good practices that could be used as a source of inspiration to the improvement of a QMS.

Personally, I place it at the same level of precedence as ISO/TR 14969 or ISO/TR 90003. It does not in any way diminish the outcomes of IMDRF work.

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