Medical Device Software Standards

One of the areas of significant growth in medical devices has been the role of software – as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices.

The low barriers to entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients. Some of the reasons for this have been lack of regulatory clarity (it’s not always clear what regulations apply, or if a software product itself qualifies as a medical device), and consequently little or confusing guidance from regulatory authorities has been provided, as well as a lack of standards to guide developers.

In this white paper:

  • When is software considered a medical device?
  • The IEC 60601 standard and medical device software
  • IEC 62304 for stand-alone and component medical device software
  • IEC 82304: A dedicated health software system standard
  • Progress toward a common framework for health software

About the Author:
Brian Goemans is a Senior Consultant and Country Manager of Emergo's South Africa office.