Critical Shifts in Biological Evaluation: Inside the New ISO 10993-1 Risk Management Framework

Available on demand.

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 this transition 

Who Should Attend: This session is essential for regulatory affairs professionals, quality managers, and R&D teams involved in medical device development and biological safety assessment. Whether you're preparing for upcoming changes or seeking to optimize your current processes, this discussion will provide actionable insights for maintaining compliance and efficiency. 

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 

Register now to gain critical insights into these industry-shifting changes and ensure your organization is prepared for what the transcript reveals to be "one of the major changes in the standard" - the requirement to apply device risk management to biological evaluation. 

Certificate of Participation available upon request for live attendees.