IEC 62304 2nd Edition draft ready for public comments
By Mitch on Friday, 7 February 2025, 15:21 - Standards - Permalink
BS EN IEC 62304 Ed2. Medical device software - Software life cycle processes is published for public comments on BSI website!
This new draft version of the standard is really an improvement, compared to the 20215 version!
The picture would be perfect if it weren't plagued by the design specification of this standard. It states that 2 software process levels replace the 3 software safety classes. These two levels are misaligned with FDA guidances and with current SW development practice. I already analysed the situation in a previous post.
My concerns about this misalignment are still valid with this draft version.
In its current state, and if the definition of sw levels is kept as is, this standard bring unnecessary overhead on manufacturers with software in class B.
This design specification was the input data of the working group. Thus, they couldn't do otherwise.
Don't hesitate to comment on BSI website. You won't have much time. Comments are closed by the 12th February 2025!
