Biological Evaluation and Biocompatibility of Medical Devices Used in Dentistry

With the release of the updated ISO 10993‑1 and ISO 7405 standards in 2025, requirements are evolving and may directly impact the biological evaluation of your medical devices used in dentistry. How can you ensure your medical devices remain fully compliant?

In this webinar, you will learn:

What are the key updates of both standards? New considerations for medical device categorization according to ISO 10993‑1:2025, an approach that may reshape your existing biological evaluations, and new recommendations for testing and toxicological assessments of medical devices used in dentistry in ISO 7405:2025.
How to manage the specific features of medical devices used in dentistry? For example: in‑situ polymerizing/curing materials, active substances, and degradable/absorbable medical devices.
What essential actions are required to keep your technical documentation fully aligned with regulatory and standards‑based requirements?

Who Should Join?

Regulatory Affairs Professionnals: Ensure compliance with changing biocompatibility requirements.
Medical Device Manufacturers: Optimize your biological evaluation and/or testing strategies for faster approvals and improved cost efficiency.
Quality & Risk Management Teams:Understand the impact of the new updates on product safety and risk assessments.

In Summary:

This webinar is essential for all stakeholders involved in the safety and compliance of medical devices used in dentistry.