Biological Evaluation of Medical Devices, including Chemical Characterization

Oct
7
Date: 7th October 2020 -
16th October 2020
Time: 09:00 - 12:45
Duration: 4 Virtual Sessions
Venue: Online
Address: 7, 9, 14, 16 Oct 9:00-12:45
320.00pp
Event details:

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.

Content includes:

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
Case study


The course will include live device examples, as well as a group exercise.

Who should attend: 

Medical Technology Professionals

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Per delegate: €320.00
(plus VAT)
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Per delegate: €520.00
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