Webinar: Reprocessing of Reusable Medical Devices - Mastering Critical Reprocessing Parameters

This webinar addresses the growing challenges of safe and compliant reprocessing in an increasingly regulated and technically complex environment. Insufficient control of cleaning, disinfection, and sterilisation processes can lead to patient risk, failed validation studies, increased costs, or regulatory rejection. The focus of the webinar is on how to comply with regulatory and authority requirements, what to prepare for validation studies to save time and cost while avoiding rejection of submissions or failing validation studies. From daily practical perspective the performance of validation studies, including the identification, mitigation, and handling of critical reprocessing parameters will be presented.

Speaker:

• Anja Friedrich, General Manager Eurofins Medical Device Testing France
• Dr. Alina Sieber -Study Director for Reprocessing Validation in Eurofins Medical Device Testing Laboratory Munich

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 safe costs and time and avoid rejection of submission and/or failing the studies:

• Risk-Based Approach
• Reprocessing Procedures
• Reprocessing Instructions
• Preparatory Work for Validation Testing
• Lifetime Evaluation for Reprocessing

Performance of validation studies and mitigation/handling of critical parameters:

• Manual and Automatic Cleaning
• Manual and Automated Disinfection
• Residual Testing
• Sterilisation
• Drying Time

Who Should Join?

• Regulatory Affairs Professionals
• Medical Device Manufacturers & Product Development Teams
• Quality, Risk & Validation Experts

Request the recording