This panel was recorded 21 November 2024. Please join us live for future shows for the chance to participate in the chat and ask your own questions! You can sign up for these events and see more free thought leadership content in the ⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠at RQMplus.com.

Thank you for tuning in. 🙏

As significant changes to ISO 10993-1 loom on the horizon, manufacturers across MedTech are seeking clarity on what's coming and how to prepare. Join our expert panel for an essential discussion on these upcoming revisions to ISO 10993-1 and their far-reaching implications for biological evaluation processes.

Our panel will provide actionable insights into:

The most significant upcoming changes to ISO 10993-1 and their implementation timeline
Comprehensive guidance on applying the ISO 14971 device risk management framework to biological evaluation, including, new approaches to risk estimation, considerations for reasonably foreseeable misuse, practical implementation strategies

Live! #84 – Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework

Powered by Wave AI