Development of a Global Qualification and Validation Strategy for UV-C Based Reprocessing Systems: Performance, Microbiological, Safety, and Regulatory Testing Considerations
Speaker: Michele Cavalleri, Senior Scientific Director, Italy
Date: 22 October 2026
Time: 15:00 - 16:00 CET
Language: English
In this webinar will be addressed the growing challenges of safe, compliant, and sustainable reprocessing in an increasingly regulated and technically complex environment. Insufficient control of UV-C disinfection cycles for probes and scopes can result in patient risk, failed validation studies, increased time-to-market, and regulatory rejection.
This webinar will focus on how to meet regulatory and authority requirements, how to prepare effectively for validation studies to save time and costs, and how to avoid submission rejections or failed validation programs. We will also present the design and execution of validation studies for UV-C-emitting devices intended for US FDA submissions and European certification, including the identification, mitigation, and management of critical UV-C reprocessing parameters.
In this webinar, you will learn:
How to comply to regulations and authorities requirements, which critical parameters you may face with reprocessing and what to prepare for validation studies to save costs and time and avoid rejection of submission and/or failing the studies:
- Introduction to UV-C emitters and their biocidal properties
- Regulatory background and requirements (US, EU)
- Testing strategies
- Preparatory Work for Validation Testing
- Performance of validation studies and mitigation/handling of critical parameters:
- Automated Disinfection using UVC-based devices
- Case study of UV-C-based high level disinfection for US FDA 510(k)
Who Should Join?
Regulatory Affairs Professionals:
Strengthen your understanding of regulatory and authority expectations for UV-C-based medical device reprocessing, validation, and learn how to avoid deficiencies, study failures, or submission rejections.
Medical Device Manufacturers & Product Development Teams:
Gain practical guidance on designing effective UV-C-based validation strategies that reduce time and costs while ensuring safe and compliant reusable ultrasound probes.
Quality & Validation Experts:
Enhance your risk-based approach to UV-C-based reprocessing by understanding critical parameters, lifetime evaluation, and validation study performance to ensure consistent process control and product safety.