Biological Evaluation of Medical Devices, including Chemical Characterization

May
27
Date: 27th May 2020 -
5th June 2020
Time: 09:00 - 12:45
Duration: 4 Virtual Sessions
Venue: Online
Address: 27 & 29 May 3 & 5 June 9:00-12:45
Member cost: €320.00 pp
Non Member cost: €520 pp
PO to Irish Medtech Skillnet
Event details:

Biological Evaluation of Medical Devices, including Chemical Characterization

27/05/2020 – 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.

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Per delegate: €320.00
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