Quality Training

Biological Evaluation of Medical Devices, including Chemical Characterization

Objectives

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

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.

Who should attend

Medical Technology Professionals

Qualification

Certificate of Attendance

Upcoming dates:

Location
Dates

Online, Online
7, 9, 14, 16 Oct. (4 Virtual Sessions: 9:00-12:45)
Book now

Course

Biological Evaluation of Medical Devices, including Chemical Characterization

Training Days

4 Sessions 9:00-12:45

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €320
Non-member rate: €520
* Cost quoted per person