EU MDR Transport Validation Of Medical Device

Common expected questions are whether a non-sterile medical device expected to perform transport validation? Is it mandatory to perform transportation test under laboratories? Alternative methods for transport validations. Transport validations are performed to examine the suitability of packaging compatibility and safety.  The transportation and the storage must not affect the properties of medical device ie, …

An Overview of Medical Device Packaging Validation

Do you know why medical device packaging is so important? Usually proper packaging is required by the medical device is to avoid, physical damage, biological contamination, and any other external disturbance. The other motive is the proper identification of the device. The medical device packaging validations are mostly required for terminally sterilized medical devices. Because …

Risk Evaluation Approaches- ALARP Vs AFAP

As-Iow-as-reasonably-practicable approach(ALARP) - is that the residual risk shall be reduced as far as reasonably practicable and this approach can be used as part of risk control options analysis. Risks for which the probability cannot be estimated would normally use the as-low-as-reasonably-practicable approach. the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration …

Risk Management under MDR

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 …

MDR Rules for Information Supplied on the Labels

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 …