Episode #8: Biocompatibility Testing Strategy an Overview of Risk Assessment Based Testing Strategy

Powering the Future

ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. ISO 10993-17, ISO/TS 21726 specifically discusses the determination of allowable limits for substances leachable from medical devices based on a toxicological risk assessment of medical device constituents.

In this podcast, the speaker, Dr. Shailendra Singh, shares key insights with regard to ISO 10993-1 Biological evaluation of medical devices. Dr. Singh holds extensive experience in the fields of Toxicology Research, Regulatory Affairs, Quality Assurance and Business Development.

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