Join us for an in-depth exploration of cutting-edge practices in biological evaluation and toxicology for medical devices. In this advanced course, we’ll unravel the significance and challenges surrounding the latest ISO 10993-17 standard. Learn to harness the power of novel concepts like the toxicological screening limit (TSL) and estimated exposure dose maximum (EEDmax) embedded within the ISO framework.
Discover the evolving landscape of biological testing, placing a spotlight on innovative in vitro and in silico alternatives, read-across methodologies, and Next-Generation Risk Assessment Methods (NAMs). We will also delve into the complexities of ‘difficult’ endpoints such as neurotoxicity and genotoxicity, gaining insights into effective evaluation strategies.
Navigate the intricate web of medical device regulations, with a focus on the General Safety and Performance Requirements (GSPR) outlined in the Medical Device Regulation (MDR). Gaining knowledge in addressing critical aspects like absorption, distribution, metabolism, and excretion, as well as the management of CMR (Carcinogenic, Mutagenic, Reprotoxic) substances.
Prepare to confidently engage with regulatory authorities by equipping yourself with the knowledge to handle their inquiries effectively. Engage in scenario workshops designed to apply theoretical learning to practical situations, fostering a comprehensive understanding of real-world challenges.
Join us for this comprehensive training where theory meets application, empowering you to navigate the intricate landscape of biological evaluation and toxicology for medical devices.
By completing this course, you'll gain advanced expertise in conducting biological evaluations, enabling confident navigation of regulatory standards and methodologies. Equip yourself with the practical skills needed to ensure the safety and compliance of medical devices, enhancing your professional capabilities.
- Deep dive into the new ISO 10993-17 – impact and challenges
- How to utilize the new concepts included in ISO 10993-17 such as the toxicological screening limit (TSL) and estimated exposure dose maximum (EEDmax)
- What biological testing looks like – emphasis on in vitro/ in silico alternatives, read-across, NAMs
- Focus on ‘difficult’ endpoints e.g. neurotoxicity and genotoxicity
- Addressing the medical device regulation (MDR) general safety and performance requirements (GSPR) effectively e.g. the absorption, distribution, metabolism and excretion, and CMR substances.
- How to be prepared for questions from authorities
- Scenario workshops