The link provided is to FDA’s webpages on the 510(k) clearance process. This provides general information on 510(k) premarket submission requirements and is not specific to software.
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.