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CER according to the MDR
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
What is a Medical Device?
A medical device is any device intended to be used for medicinal purposes by physical actions. MDR defines Medical device as: ‘’ any
What is MedTech?
MedTech, or medical technology, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing,
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