Software Release Note - Class A stand alone software medical device

[Sue789]

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

 

[yodon]

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.

 

[Sue789]

Yodon, thank you for your quick response.
Sue