For me-too medical devices, on what basis should manufacturers choose biological tests to conduct?

Manufacturers producing a me-too medical device intended for implantation in the human body, conducting a full biocompatibility study including implantation effect that takes more than one year does not seem logical. With the availability of a reference medical device of the same material & intended use, how can the manufacturer choose the required biological tests?
Analytical toxicology Clinical and translational toxicology Medical devices Molecular and biochemical toxicology Regulatory and Safety Evaluation
Charles Az
Demonstrating biologicaal equivalence with the current known products in key tests will be a good place to start. 

Post an Answer

Sign In to Answer