ISO 10993-1 Revised: what’s changing and why it matters (11134)

The revised ISO 10993-1 standard introduces substantial changes to the way biological evaluations are planned, performed, and justified.

The 2025 update reinforces a robust risk-based approach, strengthens the integration of chemical characterization, and raises expectations for both the Biological Evaluation Plan (BEP) and the Biological Evaluation Report (BER). It also updates device categorization, clarifies testing expectations, and formally introduces the consideration of reasonably foreseeable misuse.

Join our webinar for a clear and structured overview of the key updates in the 2025 version and their practical implications for your biocompatibility strategy. Through concrete examples, we will explore how these changes affect your evaluation approach, what adjustments are needed in current practices, and where open questions or uncertainties may remain.

Whether you are developing new medical devices or maintaining the compliance of existing ones, this session will support you in aligning with the latest regulatory expectations and confidently navigating the revised ISO 10993-1 landscape.

Target group:

• Regulatory Affairs
• Quality Management
• Development and Production
• Product Management
• Risk management professionals in the medical device industry
• Pre-Clinical Evaluation
• Biocompatibility Evaluation

Duration: approx. 90 minutes
Presentation language: English
Speaker:  Séverine Colas

Note on contingent call-off: When booking this webinar described here, one unit will be deducted per participant.

Especially for groups - Your benefits at a glance

• Attractive special prices or discounts for entire teams or small groups.
• On request, we offer customised inhouse-packages that are perfectly tailored to the needs of your department or company.
• Book Streaming+ option: Take advantage of our flexible Streaming+ format, which also allows you to have an interactive live Q&A session with the speaker to clarify your questions directly with the expert.

Feel free to contact us by email at info(at)alphatopics.de or by phone - we look forward to your enquiry.