Biological Evaluation of Medical Devices, including Chemical Characterization
ObjectivesVirtual 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.
Content includes27/05/2020 – 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
29/05/2020 – 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
03/06/2020 – 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
05/06/2020 – 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
- Case study
The course will include live device examples, as well as a group exercise.
Who should attendMedical Technology Professionals
QualificationCertificate of Attendance
7, 9, 14, 16 Oct. (4 Virtual Sessions: 9:00-12:45)