The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I ...
If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) fall under new classification requirements on Nov. 25, 2021, following numerous ...
Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received ...
TOKYO--(BUSINESS WIRE)--The In Vitro Diagnostics Division of PHC Corporation (hereafter, PHC IVD), a provider of medical devices and diagnostics, today announced that it has received European Union ...
Infermedica earns EU MDR Class IIb certification, validating its AI platform’s safety, clinical rigor, and regulatory compliance. With this certification, we’re proud to demonstrate that our solutions ...
BETHLEHEM, Pa., Dec. 5, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading provider of private-label orthopedic and spinal implants, proudly announces that it has received Medical Device Regulation ...
Health ministry issues draft notification with various amendments in MDR, 2017: Gireesh Babu, New Delhi Thursday, December 18, 2025, 08:00 Hrs [IST] The Union health ministry has ...
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) fall under new classification requirements on Nov. 25, 2021, following numerous ...
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