Apr 8, 2015

The International Medical Device Regulators Forum (IMDRF) has published new guidelines for how software developers whose products are considered medical devices may be affected by quality management system regulations that currently apply to more conventional device manufacturers.

The guidelines specifically targets software as a medical device (SaMD), which the organization defines as software intended to function as a medical device, not software used to control medical device hardware.

Acknowledging that many software developers have not traditionally been familiar with quality system and good manufacturing practice requirements more often associated with hardware and device manufacturers, the IMDRF’s SaMD Working Group identifies key QMS principles to which SaMD developers—effectively medical device manufacturers—should adhere. The guidance references sections of ISO 13485:2003 as bases for principles and recommendations for SaMD developers.

Four broad principles for SaMD QMS compliance

The four major QMS principles identified by the IMDRF for SaMD may seem routine to other types of device manufacturers, but not necessarily for software developers just learning about medical device regulatory compliance.

First, a proper SaMD quality system should stipulate a governance structure focused on product safety, effectiveness and performance.

Second, such a QMS should include scalable quality processes applicable across all stages of a SaMD product’s lifecycle.

Third, product lifecycle processes should be scalable and suited to a SaMD’s type and the size of the product’s developer.

Fourth, the developer’s governance should support the SaMD’s lifecycle management processes and activities.

The IMDRF also addresses QMS issues including product planning, risk management, document control and configuration management, based on ISO 13485 requirements but also including examples of how ISO 13485 requirements and principles would apply specifically to software products considered medical devices. As more and more software developers enter the medical device sector, IMDRF guidelines should help ensure QMS compliance for firms whose products fall under the SaMD category.


  • Stewart Eisenhart