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 course 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 sensitisation 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 course, attendees will feel more confident on how and when to use extractables & leachables in vitro data in the biological risk assessments. One full day dedicated to an overview of the methodologies applicable to biocompatibility assessment of medical devices and a half-day focused on the regulatory acceptance of these in EU/US/ROW.