Developing a cutting edge medical device can be really fun and exciting. There’s always something to test and do and learn from. You have that great feeling you’re changing the world. However, ...

This webinar will discuss in detail the existing and proposed requirements for the FDA's DHFs, DMRs, DHRs and the MDD's TF/DD.

Medical device manufacturers must maintain a detailed Device History Record (DHR) to meet FDA requirements and ensure ...

Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers" training has been added to ...