Shape’s CE mark under the EU MDR encompasses its Impede and Impede-FX embolisation plugs and Impede RapidFill delivery ...
If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...
This week in Pedersen's POV, our senior editor finds humor in the European Commmission's plan to simplify the EU Medical ...
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 ...
Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical ...
The course offers market opportunities by addressing the need for understanding and implementing the role of the Person Responsible for Regulatory Compliance (PRRC) under MDR and IVDR, critical for ...
BUCHAREST, Romania & SANTA CLARA, Calif.--(BUSINESS WIRE)--Bitdefender, a global cybersecurity leader, today announced a new cybersecurity breach warranty program for businesses that adopt its managed ...