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Biological Risk Assessment for Medical DevicesEssential Training for Medical Device Developers & Manufacturers
The new Regulation (EU) 2015/745 (Medical Device Regulation) and recently published new standards regarding biological risk assessment of medical device, in particular EN ISO 10993-1:2020 (basic principles), EN ISO 10993-18:2020 (chemical material characterization), ISO/TS 21726:2019 (Threshold of Toxicological Concern) and EN ISO 10993-17 (toxicological risk assessment) cause drastic challenges to the medical device industry. Therefore, this course is intended to...Continue reading
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Issues to be covered
- Regulatory background (MDR) and significance of “harmonized standards”
- Overview about EN ISO 10993 series of standards
- EN ISO 10993-1:2020 – Basic principles for biocompatibility assesments
- EN ISO 10993-12:2021 – Basic principles for sample preparation
- EN ISO 10993-18:2020 – Requirements for chemical material characterization
- ISO/TS 21726:2019 and EN ISO 10993-17:2023 – Basic principles for toxicological Risk Assessments
- Special requirements provided in the FDA biocompatibility guideline dated 08 September 2023
- “Bridging Approach” strategies: Change management and justification for waiving animal testing
- How to prepare a Biological Evaluation Plan and Biological Evaluation Report
Who should attend
- Regulatory and quality management professionals involved in the preparation of technical files/design dossiers
- Project managers responsible for product design and development
- Quality assurance managers, internal and external auditors responsible for compliance with normative and regulatory provisions for medical devices
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.
Benefits to the Participants
Upon completion of the course, participants will be able to:
- Apply the principles set out in EN ISO 10993-1 to meet international requirements
- Correctly plan the biological risk assessment process, select the required biological and chemical endpoint testing
- Cooperate with consultants and test laboratories and support/develop a summarizing biological evaluation report
- Understand the requirements of TTC-based chemical material characterization testing and toxicological risk assessments
- Understand the requirements for “bridging approach” strategies to avoid unnecessary animal experimental testing
About The Lecturer
