What is Biocompatibility? What is Biocompatibility? – “Medical devices that come into direct or indirect contact with the body” are assessed “for the possibility for an unacceptable adverse biological reaction caused by contact of the device’s component materials with the body.” The term Biocompatibility is described for the specific property of material being compatible…
In the NAMSA’s website, it is stated that the biological testing or evaluation is conducted by characterizing medical devices based on nature and duration of body contact, assessing the selection of raw materials used for construction, reviewing the manufacturing processes, identifying minimum biological end-points of concern and evaluating any existing research data available for addressing…
Benefit Risk Analysis: When the overall residual risk remains unacceptable and further risk control is not practicable, then there would be a need for risk-benefit analysis. In a risk-benefit analysis, a manufacturer shall review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk and hence a…