Biocompatibility for Medical Devices
12:00 – 12:30
The GARDskin Medical Device assay for assessing the skin sensitizing potential of medical devices: A case study on the use of in vitro data in the biological evaluation for CE marking according to MDR
- A proof-of-concept study using the GARDskin Medical Device assay to evaluate the skin sensitizing potential of medical device materials using both polar and non-polar extraction vehicles (ISO 10993-12).
- A case study using in vitro data for the endpoints of cytotoxicity, skin irritation and skin sensitization in the biological evaluation for CE-marking according to MDR to avoid animal testing while accelerating time to market
Speaker
Dr Andy Forreryd
Scientific Liason at SenzaGen
