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 recent progress in applying New Approach Methodologies (NAMs) for skin sensitization testing within the ISO 10993 framework, including current regulatory developments and data from GARD^®skin for Medical Devices.

Our group company ToxHub will also present, sharing insights on regulatory strategies for substance-based medical devices in line with MDR, while VitroScreen will attend to discuss testing approaches, including support for mode of action and classification.

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

Presentations

“Building Confidence in New Approach Methodologies (NAMs) for Skin Sensitization 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.

“Biocompatibility evaluation of substance-based medical devices”

Friday, 7th Nov | 11:40 – 12:10 CET

👤 Speaker: Dr Carla Landolfi

Key takeaways:

• Overview of biocompatibility evaluation for substance-based medical devices under ISO 10993 and MDR.
• Testing strategies: in vitro, in vivo, and non-testing approaches.
• Regulatory challenges and best practices for ensuring patient safety.