The document at the link listed is an excerpt from a warning letter issued to Linweld Inc. on 8/2/99. This excerpt cites Part 11 violations extensively. Its an example of detailed Part 11 enforcement.
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
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