Episode description
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.
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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:
00:00 Introduction to RQM+ and ISO 10993-1
02:53 Overview of ISO 10993-1 Updates
05:50 Key Changes in Biological Evaluation
08:23 Device Classification and Contact Duration
10:45 Implementation Timeline and Regulatory Considerations
13:32 Risk Estimation and Biological Evaluation
16:41 FDA Guidance and Non-Harmonization Issues
29:09 Navigating Device Categorization and FDA Feedback
31:18 Balancing Testing Burdens and Biological Safety
33:14 Understanding Reasonably Foreseeable Misuse
35:45 Challenges in Risk Assessment and Off-Label Use
39:49 Implementing ISO 14971 in Biological Evaluation
41:31 Modified Biological Effects and Device Categorization
43:31 Addressing Repeated Use of Single-Use Devices
47:16 In-House vs. Outsourced Testing for E&L
50:47 Key Advice for Manufacturers on Upcoming Changes
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