Biocompatibility and Toxicological Risk Assessment of Medical Devices - The Notified Body Perspective

This training program will be particularly useful for quality and regulatory professionals involved in preparing technical files and design dossiers for medical devices and is also suitable for medical device manufacturers, regulatory professionals, quality assurance professionals, toxicologists involved in biocompatibility studies, internal and external auditors, consultants, and anyone involved in implementing the standards.

The course will cover the following topics:

• Basic biocompatibility concepts
• Biocompatibility testing strategies
• Updates on revised standards
• Biocompatibility assessment from the Notified Body perspective, according to ISO 10993-1:2025
• Toxicological risk assessment according to ISO 10993-17:2023

Biocompatibility is the biological evaluation of Medical Devices in compliance with the standard ISO 10993-1: 2025 “Requirements and general principles for the evaluation of biological safety within a risk management process”. The standard puts forth the requirements pertaining to biological evaluation of medical devices, general principles governing biological evaluation, categorization of medical devices, evaluation, additional data, risk assessment and interpretation and the biological tests followed by gap analysis for the medical devices based on categorization. The Biocompatibility assessment in perspective of Notified Body will be discussed in this training program which is a vital information for manufacturers during evaluation of technical Files and Design Dossiers by Notified bodies. The basics and importance of Toxicological risk assessment in compliance with ISO 10993-17:2023 will also be discussed during the session which is an essential information required by the Notified Body. This standard explains the method for determination of allowable limits for substances leaching out of Medical Devices and helps in estimating allowable limits through a systematic approach towards toxicological risk evaluation of hazardous substances present in Medical Devices.

This training will provide participants an insight of ISO 10993-1: 2025, (Requirements and general principles for the evaluation of biological safety within a risk management process) and ISO 10993-17:2023 (Biological Evaluation of Medical Devices – Establishment of allowable limits for leachable substance). It will be helpful for Quality and Regulatory people who are involved in preparing technical files and Design Dossiers. It gives a hands-on experience/knowledge of Biocompatibility assessment, testing strategy and Risk Assessment Approach.

Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.

Participants who successfully complete the training program will receive a TÜV SUD certificate.

Basic knowledge of medical devices and biocompatibility, or experience in medical device and pharmaceutical toxicological evaluations, is preferred.