Software in Medical Devices, by MD101 Consulting

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Latest news about IEC 62304 2nd Edition

Want to see latest news about IEC 62304 2nd Edition?
Have a look at this thread on Elsmar Cove Forum: Update on IEC 62304 revision.
This thread contains an interesting discussion about the topics that are being amended in IEC 62304 by IEC working group:

  • Safety classes,
  • SOUP,
  • Legacy software.

Enjoy.

Note: for those who don't know Elsmar Cove forum, it's probably the best forum about quality management and standards.

EDIT: elsmar cove forums is dead, see RIP elsmar cove.



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