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Software Release Note - Class A stand alone software medical device

S

Sue789

Involved In Discussions
#1
#1
I have a Class A stand alone software medical device
Can anybody tell me what I need to include in a Software Release Note or provide an example?
The low risk software is for the EU market.
I am not a Software specialist so this might seam a dumb question
 
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Y

yodon

Staff member
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#2
#2
Not a dumb question! :)

ANSI/AAMI/IEC 62304 is the harmonized standard for software lifecycle. Per that standard, for class A software, release documentation includes:
  • known residual anomalies (risk evaluation of each is NOT required for Class A)
  • The version information of the release being made
  • How the software was created
They don't make a distinction between public / private info but we've always made the first 2 bullets public and kept the 3rd one as internal info.

If this is a revision to an already-fielded version, I would recommend documenting (summarizing) the changes between the releases.

There are more things than just documentation associated with a release so be sure all those are covered as well.
 
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