ISO 10993 webinar series: Carcinogenicity and Reproductive Toxicity (Part 3 of 7)

IMPORTANT ASPECTS IN CARCINOGENICITY AND REPRODUCTIVE TOXICITY 

Carcinogenicity and reproductive toxicity testing of medical devices is quite rare because the requirement is limited to applications of new materials used in implanted devices and those with a permanent contact.

Before advancing to clinical trials, materials that are found to be genotoxic in mammalian cells must be evaluated for carcinogenicity in animals. Female animals should be used to test reproductive toxicity of intrauterine devices (IUDs) and other long-term contact devices that are expected to come into direct touch with reproductive tissues or the embryo/fetus. Reproductive toxicity testing may be required for energy-depositing devices (electromagnetic, ultrasonic, or ionic radiation) as well as resorbable or leachable materials and the equipment.

In this webinar, we will go through the standard and regulatory requirements for medical devices, as well as considerations for carcinogenicity and reproductive toxicity.

Date: 19 November 2021, Friday
Time: 9:00 AM CET/ 1:30 PM IST/ 3:00 AM EST (Session 1)
          2:00 PM CET/ 6:30 PM IST/ 8:00 AM EST (Session 2)
Duration: 1h (including 15 mins for Q&A)

KEY TOPICS COVERED:

• Evaluation of carcinogenicity and reproductive toxicity

• Standards involved in testing and evaluation

• Safety assessment and global regulatory requirements

• Guidelines on the benefit-risk assessment  

• Q&A

ABOUT THE SPEAKER

Dr. J.S.I. Rajkumar

Biocompatibility Expert and Auditor, TÜV SÜD South Asia, Medical and Health Services 

Dr. J.S.I. Rajkumar is a Biocompatibility Expert and Auditor based in India. He currently oversees reviewing of Biocompatibility Assessment reports in TÜV SÜD South Asia, Medical and Health Services.

Dr. Rajkumar holds a Doctoral Degree in Toxicology. He has vast experience in the research of Toxicology, Toxicological Risk Assessment of Pharma Products and Medical Device Testing. Prior to his current role, he held key technical positions at CRO’s and led the development of Biocompatibility testing and Chemical Characterisation of medical devices. He is also an Internal Auditor for ISO 17025 : 2015.

Dr. Rajkumar gained extensive knowledge in Biocompatibility and Chemical Characterization of medical devices through his professional experience as a Study Director and Study Scientist in many preclinical studies with medical devices. He has worked for different class products of medical devices in various animal models based on different regulatory guidelines.

IS0 10993 WEBINAR SERIES 

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