Preparing for the revised biological safety requirements
The revised ISO 10993-1:2025 introduces important changes to biological safety evaluations for medical devices. Manufacturers are now expected to take a more risk-based approach, consider foreseeable misuse and lifecycle factors earlier, and strengthen material characterisation within the evaluation process.
In this on-demand webinar, TÜV SÜD expert Dr. Katharina Weidmann will explain the key updates, highlight the differences from the previous edition, and share practical guidance on what they mean for EU MDR compliance.
Key takeaways
Practical application
Understand how to apply ISO 10993-1:2025 in biological evaluations for medical devices.
Key updates explained
Explore the most important changes compared with ISO 10993-1:2020.
Compliance insights from TÜV SÜD
Learn how the revised requirements may affect biological evaluation planning and gain expert guidance from TÜV SÜD to support EU MDR compliance.
Webinar details
- Agenda:
- Welcome & Introduction (5 min) – Rachele Nardella
- Presentation (45 min) – Dr. Katharina Weidmann
- Q&A (10–15 min) – Moderated by Rachele Nardella
Who this webinar is for
This webinar is designed for:
- medical device manufacturers
- regulatory affairs professionals
- biological safety and biocompatibility specialists
- quality and compliance professionals involved in EU MDR readiness
Speaker
Dr. Katharina Weidmann
SPS for Biocompatibility, TÜV SÜD
Moderator
Rachele Nardella
Sales Manager, TÜV SÜD
