FDA has provided a tool that allows creation of a premarket submission eCopy that is meets FDA requirements. The guide for this tool is at the link provided.
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.