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

Listen on: Apple Podcasts | Google Podcasts | Spotify

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

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