As global regulatory pressures tighten and supply chain challenges increase, medical device manufacturers are increasingly considering changes to sterilization modalities—whether due to material compatibility, environmental impact, or technology accessibility. However, transitioning from one sterilization method to another is a complex process that requires a rigorous, structured decision flow to ensure patient safety, product efficacy, and regulatory compliance.
Sterigenics is proud to sponsor a webinar from our exceptional leaders at the Sotera Health Company.
Join us as our presenters share their combined industry knowledge and vantage point on Navigating the Decision Flow: Changing Sterilization Modalities for Medical Devices.
This webinar will provide a comprehensive overview of the critical considerations and step-by-step process involved in changing sterilization modalities for medical devices. Topics will include feasibility assessment, risk-based decision making, material compatibility studies, and the planning and execution of validation testing, and maintaining regulatory compliance. Additionally, this webinar will explore the regulatory landscape, with guidance on engaging with global regulatory bodies, compiling robust technical documentation, and navigating submission requirements.
Attendees will gain insights into:
- Key drivers prompting sterilization modality changes
- Early feasibility testing and risk assessment frameworks
- Designing and interpreting validation studies, including bioburden, biocompatibility, dose audit, and package integrity
- Understanding regulatory pathways and expectations in the U.S. and EU
- Best practices for cross-functional collaboration between R&D, Quality, and Regulatory Affairs
Whether you are planning a modality change due to EO reduction initiatives, supply chain challenges, material compatibility issues or the adoption of newer methods such as X-ray or nitrogen dioxide, this webinar will equip you with the practical knowledge to manage the transition effectively and compliantly.
Who Should Attend:
Regulatory Affairs professionals, Quality Assurance/Validation Engineers, R&D Managers, Sterilization Specialists, and anyone involved in medical device lifecycle management.
Learn more about the presenters below.
