The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA issued final guidance on the information devicemakers should include in test report summaries, test protocols and complete test reports for non-clinical bench performance testing for premarket submissions. Read More
The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Read More
The European Commission released new details on what datasets devicemakers should include in the Eudamed database for unique device identifiers under the new Medical Device Regulation and In Vitro Diagnostic Regulation. Read More