Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

The European Union's Medical Device Regulation (EU MDR) has become much more sophisticated and specific. Since taking effect in May 2017 the EU MDR includes more challenging protocols, including new ...

KIRKLAND, Wash.--(BUSINESS WIRE)--Cardiac Dimensions ®, a leader in the development of innovative, minimally invasive treatment modalities to address patients suffering from heart failure with ...

This certification was granted for the entire 'CART PLATFORM,' centered on the ring-type medical device equipped with ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...

Signifier Medical Technologies Limited (“Signifier”), a global leader in medical technology for sleep-disordered breathing, announces that it has achieved the EU MDR certification for eXciteOSA®, its ...