Streamlining Your CE Marking Process: Tips for Efficiency and Success
Introduction The CE marking is a mandatory conformity marking for products sold in the European Economic Area, demonstrating compliance with applicable EU directives and regulations. It ensures that medical devices meet essential safety, performance, and quality requirements for market entry in the EU. What...
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European Union Medical Device RegulationIntroduction European Union Medical Devices Regulation (EU MDR)Reasons for replacing Medical Device Directives (MDD)Medical Device ClassificationScope of EU MDRChallenges in implementing the MDREU MDR ComplianceReference Introduction European Union...