May be paywalled – 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.
Medical Device Expert News
Corrigenda for MDR and IVDR published in Official Journal
EUDAMED UDI Device Data Dictionary MDR – UDI and device data sets to provide in EUDAMED IVDR – UDI and device data sets to provide…
Priority List of Patient Preference-Sensitive Areas
Reorganization of The Center for Devices and Radiological Health Office of Product Evaluation and Quality Implementing a Team-Based Approach to Medical Device and Radiological Product…
Patient Preference Information (PPI) in Medical Device Decision-Making
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with…
dCharacterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devicehttps://www.fda.gov/media/95791/downloads
State-of-play of joint assessments of Notified Bodies in the medical device sector
Unique Device Identification: Convenience Kits