In April 2015, the International Medical Device Regulators Forum (IMDRF) released a new guidance document on the application of Quality Management Systems (QMS) for software as a Medical Device (SaMD). Public consultation was open until 2015 June and final document is supposed to be published in October 2015.
SaMD is becoming increasingly important in the medical devices industry. At the same time, its constant development brings a bunch of new complex challenges for software developers who are affected by QMS requirements. The guidelines are undoubtedly a significant step forward towards harmonizing QMS requirements for SaMD.
The objective of this document is to provide guidance on the application of standardized and generally accepted medical device QMS principles to SaMD. Also, it aims to facilitate a common understanding of how existing medical device quality management systems and standards apply to software intended for medical use.
The document targets the following audience:
- groups and/or individuals who are, or want to become, developers of SaMD;
- software development organizations (large or small) that apply good software quality and engineering practices and that may not necessarily be familiar with medical device QMS requirements;
- organizations (divisions/departments) working within established medical device quality systems that intend to communicate the linkage between medical device quality system practice and SaMD development practices.
In order to attain a common approach on the development and regulation of SaMD products, the IMDRF has published a collection of documents concerning SaMD definition and categorization.
In one of its former guidance document IMDRF has recognized two distinct types of software intended for medical purposes:
- software used to control medical device hardware;
- software designed to function as a medical device (SaMD)
The main distinction between the two is whether the software is used “to drive a hardware medical device”. The proposed document, Software as a Medical Device (SaMD): Application of Quality Management System, applies to SaMD and does not consider other types of software.
This document is a companion document to other IMDRF SaMD Working Group documents aimed at enabling convergence in vocabulary, approach and a harmonized approach for regulators and industry.
QMS Principles for SaMD
IMDRF proposes four major QMS principles for SaMD. These principles may seem self-evident for medical device manufacturers, but software developers who are not well familiarized with medical device QMS requirements may not have the same level of understanding.
According to IMDRF, an effective QMS for SaMD should include all of the following principles:
- A governance structure provides leadership, accountability and an organization with adequate resources that assures the safety, effectiveness and performance of SaMD
(outer circle in Figure 1);
- SaMD lifecycle processes – a scalable set of quality processes apply commonly across all stages of SaMD lifecycle activities (middle circle in Figure 1);
- A set of key lifecycle activities is scalable for the type of SaMD, the size of the organization and takes into account important elements required for assuring the safety, effectiveness and performance of SaMD (innermost circle in Figure 1);
- Leadership and organizational support provides a foundation for SaMD lifecycle processes which in-turn support and apply across the SaMD lifecycle activities.
The new document references ISO 13485:2003 as a base for QMS requirements for SaMD developers. The IMDFR also outlines safety concerns such as product planning, risk management, document control and gives the examples of how ISO 13485 requirements and principles would apply specifically to medical software.
As more and more software developers enter the medical device industry, IMDRF guidelines should help ensure QMS compliance for companies whose products fall under the SaMD category.
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