BIOCOMPATIBILITY TESTING STRATEGY: AN OVERVIEW OF RISK ASSESSMENT BASED TESTING STRATEGY

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ABOUT THIS EPISODE

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 regards to ISO 10993-1 Biological evaluation of medical devices. Dr. Singh holds an extensive experience in the field of Toxicology Research, Regulatory Affairs, Quality Assurance and Business Development.

EU MDR PODCAST OVERVIEW

• 01min 20sec - Challenges in the traditional approach
• 01min 57sec -The important parameters of Biocompatibility evaluation
• 05min 52 sec -The Revised Testing Strategy
• 12min 47sec -The important assessment that needs to be considered for Human Exposure Assessment
• 14min 43sec -The Advantages of Risk-based Testing Strategy

RELATED LINKS

For more information about our Biocompatibility and Toxicological Risk Assessment of Medical Devices: The Notified Body Perspective training program, visit Biocompatibility and Toxicological Risk Assessment of Medical Devices: The Notified Body Perspective