Biological Evaluation of Medical Devices, including Chemical Characterization
Virtual online delivery will describe the big-picture concepts of biological evaluation of medical devices providing a wide and comprehensive overview of the main relevant key topics and critical aspects. It offers a first-hand look at how to plan and conduct the biological evaluation, and, more importantly, how such an evaluation sits within the activities of design control and risk management by giving practical hints for the definition of pathways based on scientific rationales.
7/10/2020 – Module 1 (9.00 am – 12.45 pm)
Regulatory framework: The new EU Regulations on medical devices
EU Medical Device Regulation 2017/745: General Safety Requirements and Biological Evaluation
Evaluation and testing within a risk management process: Use of ISO 10993-1
Chemical Characterization and Toxicological Evaluation: Use of ISO 10993-18 & -17
9/10/2020 – Module 2 (9.00 am – 12.45 pm)
Sample Preparation ISO 10993-12 “Biological evaluation of medical devices -Part 12: Sample preparation and reference materials”
FAB FOUR: Cytotoxicity, irritation, sensitization and acute systemic toxicity
14/10/2020 – Module 3 (9.00 am – 12.45 pm)
Endotoxin contamination and material mediated pyrogenicity: US-FDA expectations
Genotoxicity ISO 10993-3 “Tests for genotoxicity, carcinogenicity and reproductive toxicity” & ISO/TR 10993-33 “Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3”
ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
EFFECTS AFTER IMPLANTATION: Use of ISO 10993-6
16/10/2020 – Module 3 (9.00 am – 12.45 pm)
FDA EXPECTATIONS: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Change management: Impact of changes on biocompatibility
The course will include live device examples, as well as a group exercise.
Who should attend:
Medical Technology Professionals
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.