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.