3rd Annual Medical Device Biocompatibility Conference

Berlin, Germany | Nov 6-7

Come meet us at this year’s Medical Device Biocompatibility Conference in Berlin, where SenzaGen’s chief scientist Henrik Johansson will present the pre-validation study of GARD^®skin Medical Device and discuss its implementation into ISO 10993-10.

Want to connect with our scientific team while you’re there?

Presentation

“Building Confidence in New Approach Methodologies (NAMs) for Biocompatibility Testing of Medical Devices”

Thursday, 6th Nov | 13:30 – 14:00 CET

👤 Speaker: Dr Henrik Johansson, Chief Scientist at SenzaGen

Key takeaways:

• Introduction to in vitro biocompatibility testing: Overview of available assays and their regulatory status.
• Pre-validation data from GARD®skin for Medical Devices: In vitro skin sensitization testing of Medical Device Extracts for implementation in ISO 10993-10.
• Regulatory Developments in ISO 10993-10: Inclusion of in vitro methods.
• Case study: Integrating in vitro data into CE-marking submissions.