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The proposal looks to keep up with the EU’s medical device regulations, which reclassified some categories of medical devices into higher risk classes. Read More
With a looming hard Brexit exit less than 60 days away, BSI is warning devicemakers that their CE certificates in the UK could become invalid if the UK and EU fail to negotiate an agreeable contract. Read More
The FDA rapped six device facilities for a variety of deficiencies identified during inspections, including problems with CAPAs and medical device reporting. Read More
China’s National Medical Products Administration is increasing its scrutiny of foreign manufacturers and will begin routine, risk-based inspections of foreign facilities to confirm they are in compliance with Chinese regulations. Read More