The potential of a chemical substance leached from the medical device or material to cause adverse biological reaction is considered a toxicological hazard. Risk is considered as the probability of adverse reaction in response to a specific exposure level of the hazard.
In order to quantify the toxicological threshold, such as tolerable intake, tolerable exposure, allowable limit, and margin of safety of a hazard that is acceptable for human exposure, a detailed toxicological risk assessment of each and every chemical identified through various methods needs to be evaluated. This, along with the biological studies of medical devices, will provide strong evidence for the biocompatibility of the final device or material.
In this webinar, we discuss the toxicological risk assessment of extractables/leachables from medical devices.
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Mr. Senthil Kumar
Auditor and Biocompatibility Expert in Medical and Health Services, TÜV SÜD Products Services Division
Mr. Senthil Kumar holds a Master of Philosophy in Biochemistry and is an experienced toxicologist. He is presently working as an Auditor and Biocompatibility Expert in Medical and Health Services, under TÜV SÜD Products Services Division based in India, where he is responsible for reviewing the biocompatibility assessment and toxicological risk assessments.
Mr. Senthil gained extensive knowledge in Pharmacology and Toxicology through his professional experience in various organizations as a Researcher and Study Director in a large number of in-vivo efficacy and toxicological studies. He has worked for different products research activities such as for herbal products/extracts, pharmaceuticals, bacteriophage derived products in various animal models based on different regulatory guidelines.
Other areas of expertise includes the research of non-clinical overview, toxicological profile, Common Technical Documentation (CTD), toxicological/safety assessment for cosmetics and Over-the-Counter (OTC) products.
View the rest of the ISO 10993 webinar series here.