What is Bio compatibility?

The term Biocompatibility is described for the specific property of a material being compatible with living tissue. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids. The ISO 10993-1:2018 standard defines Biocompatibility as the ability of a medical device or material to perform with an appropriate host…

What you mean by Biological Safety Testing?

In the NAMSA’s website, it is stated that the biological safety 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…

Pre-Clinical and Clinical Data

Pre-Clinical and Clinical Data Pre-clinical data are the important testing and safety data collected during research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests. Clinical data are used to prove…

Benefit Risk Analysis

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…