ISO 10993-17: 2023 - Key Changes and its Impact on Existing Processes

The ISO 10993 series of standards address the biological evaluation, or biocompatibility, of medical devices based on material, contact type and duration. These standards cover a range of biological safety scenarios and stipulate what specific evaluations must be completed. With the recent updates to ISO 10993-17:2023, there are significant changes that have been brought about to bring more clarity and relevance to medical device evaluation.

To navigate through this, our expert practitioner will delve into key aspects and extend his insights through a complimentary webinar, covering an elaborate account of the ISO 10993-17: 2023 standard along with the updated developments and impact it will bring about in its implementation.

Watch our on-demand webinar here!

Details:

• Date: Thursday, 25^th April 2024
• Time: 2.30 pm IST
• Speaker: Mr. Vaibhav Patidar

Agenda:

• Concept of Toxicological Screening Level (TSL)
• Estimated Exposure Dose (EED)
• Comparison of different EEDmax with respective toxicological threshold
• Margin of Safety (MoS) and risk acceptance criteria
• Q&A

Who should attend?

• R&D managers
• Regulatory specialists
• Managers involved in identifying risks & testing requirement

Business benefits:

• Awareness on the requirement of toxicological risk assessment along with chemical characterization.
• Detailed product understanding along with requirement of TRA.
• Detailed understanding of requirements from regulatory bodies.

Meet our expert:

Mr. Vaibhav Patidar

Executive - Toxicology

Vaibhav Patidar is an executive toxicologist at the Healthcare & Medical Devices division at TÜV SÜD South Asia Pvt. Ltd. He has completed his master’s degree in pharmacology and toxicology from NIPER, Hyderabad. He then went on to work in different global organizations for more than two years in the field of medical device biocompatibility and regulatory toxicology.

Vaibhav deals with medical device biocompatibility related activities at TÜV SÜD South Asia, including drafting and reviewing toxicological risk assessment reports, biological evaluation plans, and biological evaluation reports against applicable standards, gap analysis of biological studies with current standards and contribution to biocompatibility testing services.