How to conduct a clinical investigation of medical devices in Portugal

by AKRN Scientific Consulting

Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and appropriate experience, preferably in the proposed research...

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Does the MDR mean the end of the equivalence route for clinical evaluations?

by AKRN Scientific Consulting

In Europe, medical device manufacturers with products on the market have long used clinical data from equivalent devices to confirm the clinical safety and performance of their devices. Using clinical...

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