Biological Evaluation of Medical Devices – News from ISO10993 Standards

The web-seminar takes place in 2 training units on 2 consecutive days including breaks.

Your benefit

The participants will be involved in solving real cases, trying to find the best strategy to assess the biological safety of medical devices.


  • Introduction of the regulatory context on biological safety: ISO10993 series and FDA guidances
  • News about newly released standards and future trends
  • How to conduct a successful biological evaluation: how to prepare a biological evaluation plan
  • The essential role of the materials characterization
  • How to choose the best testing strategy: understanding the chemical characterization (Extractable / Leachable) and the biological testing
  • An introduction to the Toxicological risk assessment, a key component of a biological evaluation
  • How to prepare a biological evaluation report
  • How to deal with test failures
  • CMR and ED substance, Particles and nanoparticles, how to deal with them
  • How to integrate your biological evaluation in your QMS
  • Case studies and practical examples


Target audience
Manufactures of Medical Devices (quality management, regulatory affairs, research and development, toxicologist)
Language of training material
Basic knowledge of the medical device industry.