FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017
Medical Device Expert News
Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)
FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately
MDCG 2019-5 Registration of legacy devices in EUDAMED
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The…
Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament
Virtual manufacturing of medical devices.
TGA presentation: How the TGA regulates software, 7 March 2019
In French – The ANSM decides, as a precautionary measure, to withdraw from the market macrotextured breast implants and breast implants with polyurethane-coated surfaces –…