Ready to overcome higher obstacles for FDA registration? Deep dive into Chemical characterisation (and TRA) new requirements

Navigating the regulatory landscape for medical devices has always been a challenge. Chemical characterisation is a preliminary step in the biocompatibility evaluation of medical devices. The introduction of the FDA’s new guideline on chemical characterisation, combined with the updated ISO 10993-17:2023 standard, places a sharper focus on a more rigorous evaluation of chemical profiles and toxicological risk assessments (TRA). While these updates aim to enhance patient safety, they also introduce significant challenges for manufacturers.

This webinar is your opportunity to clarify these novelties with the guidance from Eurofins industry experts, that have daily practical insights into conducting robust risk assessments, addressing potential pitfalls, and ensuring compliance with evolving standards. The focus will be on the key elements of the new chemical characterisation guideline and what they mean for manufacturers.

With increasing scrutiny from regulatory bodies and a growing demand for transparency in the safety evaluation of medical devices, staying ahead of these requirements is no longer optional. Non-compliance could result in delayed market entry, increased costs, or even rejection of your submission. This webinar equips you with the knowledge and confidence to navigate these challenges and ensure a smooth pathway to FDA approval.

Whether you are new to regulatory processes or looking to refine your expertise, this session offers invaluable insights to help you succeed in a competitive and highly regulated industry.