Dear All
The TEAM-NB (European Association Medical devices of Notified Bodies) issues a guidance document "FAQ related to the Implementation of EN 62304 with respect to MDD 93/42/EEC" on 5th April 2013. Many useful information's are available including When software is medical device, What is software validation, SOUP and legacy software,Software risk assessment and so on. For more details refer here.
The TEAM-NB (European Association Medical devices of Notified Bodies) issues a guidance document "FAQ related to the Implementation of EN 62304 with respect to MDD 93/42/EEC" on 5th April 2013. Many useful information's are available including When software is medical device, What is software validation, SOUP and legacy software,Software risk assessment and so on. For more details refer here.
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