Now that the new 10993-1:2025 is a final publication – what has changed in the last few months and what is coming? Join NAMSA’s expert-led webinar to explore the most impactful updates in the newly revised ISO 10993-1 standard. Whether you’re in regulatory, R&D, or quality, this session will help you understand what’s changed, why it matters, and how to prepare.
This webinar discusses the practical application of several key updates in the ISO 10993-1: 2025 standard. We discuss what the greater alignment with risk management principles from ISO 14971, including the requirement to include reasonably foreseeable misuse, will mean for biological evaluations going forward. The impact of having greater clarity on contact duration when categorizing a medical device, including intermittent exposure and bioaccumulation will be assessed. We also discuss what significant changes exist between the FDIS and published versions of the standard and what uncertainties remain even after publication. This webinar specifically focuses on the key actions manufacturers should take both in the short and long term which will likely differ based on regulatory region.
Key Learning Objectives:
- Refresher on the key elements of the new version
- Understanding any impactful editorial changes during the process of moving from FDIS to publication
- Operational considerations for manufacturers such geographical expectations and worked examples
- Plans/challenges for addressing uncertainties that remain
Speakers
Principal Toxicologist
Phil is a Principal Toxicologist in the Biological Safety Department at NAMSA. His experiences in the medical device field encompass toxicology, biological safety, preclinical study design, and extensive preparation of biological and toxicological risk assessments. Prior to his role in the Biological Safety Department, he was a Study Director overseeing special/custom preclinical functional studies, preclinical safety studies, and simulated-use chemistry studies.
Toxicologist
Michelle Kelly joined NAMSA in August 2021 as a Toxicologist working in the Biological Safety and Validation Team. Prior to NAMSA, she was the Biological Safety Manager at UK Competent Authority, MHRA. Her responsibilities included serving as Principal Lead for clinical trial applications for biological safety, providing expert biological safety advice and directing the Regulatory and Safety and Surveillance Teams on compliance, vigilance and Notified Body matters. Michelle also d continues to work with key stakeholders toward the development of international standards to help innovation to the UK market. She is currently the Chair of CH/194, a committee responsible for the UK input to ISO/TC 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices. Michelle has a BSc in Biomedical and Advanced Materials from University of Limerick in Ireland, an MSc in Applied Toxicology from University of Surrey and she is a European Registered Toxicologist.
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This is a free educational webinar.
