Episode #8: Biocompatibility Testing Strategy an Overview of Risk Assessment Based Testing Strategy
Powering the Future
English - January 05, 2024 08:05 - 16 minutes - 15.4 MBBusiness Education testing inspection certification safety quality sustainability leadership security industry 4.0 technology Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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.
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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