The concept of equivalence in the European’ MedTech sector In Europe, medical device manufacturers with products on the market have long used
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
If you are failing to plan, you are planning to fail. It is crucial for all medical device manufacturers, as part of their business strategy,
The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of
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