Software in Medical Devices, by MD101 Consulting

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FAQ related to the Implementation of EN 62304 published by TEAM-NB

The FAQ related to the Implementation of EN 62304 with respect to MDD 93/42/EEC was released by Team NB, the association of Notified Bodies.
You'll find in this FAQ many hot subjects I already mentioned in this blog:

  • When software is medical device,
  • What is software validation,
  • SOUP and legacy software,
  • Software risk assessment.

This FAQ shows that the state-of-the-art is still evolving. But I think that it has reached a point of consistency and stability. Many questions in the FAQ hadn't clear answers one or two years back.

Keep going!

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