Webinar: Using in vitro data in your CE marking submission of Medical Devices
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Avoid animal testing and accelerate time to market
Join this free webinar to learn how you can avoid animal testing and accelerate time to market by using results from in vitro testing for the endpoints of cytotoxicity, skin irritation and skin sensitization in your biological evaluation for CE-marking of your medical device in line with the EU Medical Device Regulation 2017/745, the MDR.
Key takeaways
- An introduction to how in vitro testing can be used in the biological evaluation of your medical device with focus on cytotoxicity, skin irritation and skin sensitization according to MDR.
- The unique and broad applicability of the OECD approved GARD® assay for skin sensitization testing, supporting polar and non-polar extraction vehicles as recommended in ISO 10993-12.
- Several application examples and a class IIa product CE marking case study supporting ethical test solutions and faster time to market.
- Expert advisory and support in compilation of regulatory documentation for instance gap analysis of ISO standards, Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER).
The webinar will last around 45 minutes, followed by a live Q&A. If you cannot attend the live event, make sure to register to get access to the recording.