Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol
Posts published in April 2019
Medicinal products and medical devices: Coordinated approach in case of a withdrawal of the United Kingdom from the Union without a deal
Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph
Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk The FDA Continues…
FDA Classifies Suitable Accessories into Class I as Required by the FDA Reauthorization Act of 2017
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…