For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...
Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria Receive the the latest ...
The "UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course (Apr 15, 2026)" training has been added to ResearchAndMarkets.com's offering. This course, designed for medical device ...