ISO 10993-1 in practice
The latest edition of ISO 10993-1 emphasizes the connection between biological evaluation and risk management. The biological evaluation must not be treated as a stand-alone exercise, but as with risk management, should be integrated with the other pre- and post-market processes.
Join us for this practical session on how to integrate biological evaluation with risk management and technical documentation—reflecting the risk‑based approach of ISO 10993‑1.
We look forward to welcoming you to Medicon Village, where we we'll start with breakfast together, followed by our seminar “ISO 10993-1 in practice: connecting biological evaluation to your technical documentation”, focusing on how to effectively link the required documentation to your design controls and risk analysis.
📍 Medicon Village (Lund, Sweden) on May 28th, 8.15-9.30 CET. Breakfast/mingle will start from 8.15. The seminar will begin at 8.45 and will be held in English.
Meet our Quality & Regulatory Expert
Noomi Altgärde holds a PhD in Bioscience and has extensive experience working with medical devices in the development phase, with a strong focus on quality assurance and regulatory affairs. Her background provides a solid foundation for understanding the complexities faced by medical device manufacturers. Noomi is committed to translating regulatory requirements into practical, hands‑on solutions that help manufacturers and other stakeholders navigate complex compliance challenges.