Making MedTech Happen with RQM+
Making MedTech Happen with RQM+
RQM+
Live! #84 – Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework
57 minutes Posted Dec 5, 2024 at 3:00 pm.
Introduction to RQM+ and ISO 10993-1
Overview of ISO 10993-1 Updates
Key Changes in Biological Evaluation
Device Classification and Contact Duration
Implementation Timeline and Regulatory Considerations
Risk Estimation and Biological Evaluation
FDA Guidance and Non-Harmonization Issues
Navigating Device Categorization and FDA Feedback
Balancing Testing Burdens and Biological Safety
Understanding Reasonably Foreseeable Misuse
Challenges in Risk Assessment and Off-Label Use
Implementing ISO 14971 in Biological Evaluation
Modified Biological Effects and Device Categorization
Addressing Repeated Use of Single-Use Devices
In-House vs. Outsourced Testing for E&L
Key Advice for Manufacturers on Upcoming Changes
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57:42
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Show notes
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
Critical updates to device categorization and their impact on modified biological effects
Strategic considerations for maintaining compliance during
Panelists:
Taryn Meade – Director of Biological Evaluation
Stephen Bond – Senior Toxicologist
Amanda DeGraw, MS, Ph.D., DABT – Principal Toxicologist
Moderator:
Christine Santagate, RAC – Vice President of Lab Services 
Topics with Timestamps:
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