Tuesday, November 15, 2011

Guidance on the use of AGILE practices in the development of medical device software - AAMI Technical Information Report - Working Committee Draft

I had the opportunity to see an advanced copy of the document from the Association for the Advancement of Medical Instrumentation .
Agile TIR SW Committee Draft 1.0 10/7/2011 working draft
AAMI Technical Information Report AAMI/TIR XX:201X
Guidance on the use of AGILE practices in the development of medical device software
Abstract: Over the past several years, agile software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) agile practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented agile practices in their software development that answers to these questions can be documented. Having clear guidance of what practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and United States Food and Drug Administration (FDA) guidance documents when using practices to develop medical device software.
The paper describes how AGILE can bring value to medical device software, when adapted to the unique needs of medical devices.

Watch for the public version of this document, review it, and comment on it.


  1. So much medical software has been developed, especially these past few years. It does a lot of good for a medical practice to have software though.

  2. When might we expect release of the document ? Does this apply to embedded software in devices ?

  3. a. Yes, it would apply to embedded software - if that software development group uses Agile practices.

    b. I heard that the expected release date was end of the year 2011. I do not have a new projected release date.