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 on-demand webinar, we will go through the standard and regulatory requirements for medical devices, as well as considerations for carcinogenicity and reproductive toxicity.
Evaluation of carcinogenicity and reproductive toxicity
Standards involved in testing and evaluation
Safety assessment and global regulatory requirements
Guidelines on the benefit-risk assessment
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.
Sign up for the rest of the ISO 10993 webinar series here.
Middle East and Africa