IVDR compliance is not far. Some companies updated their clinical reports while vast majority of them have not Based on the risk class,
requirements for clinical evidence increase to support the safety and performance of your products.
From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), as well as a file of clinical evidence should be combined as a performance evaluation report (PER).
MakroCare with a global team of 90+ Clinicians, Diagnostic technologists, Micro Biology associates, Writers, and Scientific experts can help you achieve your Performance Evaluation goals, on time with scalable competitive cost models (unit, hourly, fte).
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