FDA Quarterly MDR Reporting Pilot Program

FDA is initiating a pilot program that would allow quarterly reporting of MDRs for certain Class I and Class II devices in situation that do not reult in death or serious injury or a correction is not needed to prevent this. Companies can apply to participate in this pilot as indicated in the FDA announcement at the link provided.

Upcoming Public Courses

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.

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