web-seminar
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.
Content
- 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
Details
Target audience
Manufactures of Medical Devices (quality management, regulatory affairs, research and development, toxicologist)
Language
English
Language of training material
English
Requirements
Basic knowledge of the medical device industry.