INTERACTIVE SESSION: Insight Session: Overview of International Standards Activities Related to Medical Software Development

A session at 2nd Annual Software Design for Medical Devices Europe

This interactive discussion session outlines several global software standards activities with regard to medical software development. Patty, standards advisor for Medtronic, as well as leader of the teams working on the revision of IEC 62304 and the creation of IEC 82304 Healthcare Software Systems, will lead the discussion via video link.

Topics will include:

  • Update on the revision of IEC 62304 Medical device software - software life cycle processes: information on the main areas of change
  • Update on the new work item IEC 82304 Healthcare software systems - background on what is driving this new work item
  • Information on the development of a guidance document on the use of agile practices in the development of medical device software

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