Medical Device Regulatory Consulting
MDR defines Risk as the combination of the probability of occurrence of harm and the severity of that harm. A Risk Benefit Analysis helps to balance the benefit with the inherent Risk. As per article 10 of MDR, Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 …
A medical device label helps to identify the individual device and to communicate with the user about the safety and effectiveness of the device. Where appropriate the labelling should use symbols and its additional explanation text should be include in information supplied by manufacturer complies with harmonised standard EN ISO 15223-1: 2012 . Apart from …
Continue reading "MDR Rules for Information Supplied on the Labels"
Medical Device CE Marking 