New approach methodologies (NAMs) for medical devices

New Approach Methodologies (NAMs) for medical devices are non-animal-based documentation strategies that can be used in biological evaluation of medical devices.

In this webinar we will cover the most recent advances in documentation alternatives to in vivo biocompatibility testing. We will review the current global regulatory acceptance of a risk-based biocompatibility approach focusing on the use of extractables and leachables data, along with in vitro testing alternatives for the irritation and sensitization endpoints. We will also discuss the status of using NAMs for future biological endpoints and which alternative testing methods are next.

The evolution of the ISO 10993 series of standards will be used a paradigm for the overall approach.

At the end of the webinar, attendees will feel more confident on how and when to use extractables & leachables in vitro data in the biological risk assessments.

One event dedicated to an overview of the methodologies applicable to biocompatibility assessment of medical devices and regulatory acceptance of these in EU/US/ROW.

European Registered Toxicologist with a MSc in Applied Toxicology and Biomedical Engineering, Paolo has over 15 years of experience in biological evaluation of medical devices and toxicological risk assessment for pharmaceutical products. He is Senior Scientific Director at Eurofins Medical Device Testing Europe, member of ISO TC 194 and CEN TC 206 and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna. He is a former Healthcare Engineering HAS consultant for EU Commission.