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 Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.
October 13-15, 2026
Limited Early Bird Registration: $995 / person
Non refundable but transferable.
Or just email training@softwarecpr.com for more info.