S(p)oiler Alarm – Reusable Medical Devices, how to proceed and what is new?
Reister now for the free live webinar "S(p)oiler Alarm – Reusable Medical Devices, how to proceed and what is new?"
Access the webinar on-demand (German Version)
Access the webinar on-demand (English Version)
About the webinar
The requirements for reusable medical devices for submission on different markets and recertification has been increasing significantly during the last years. Each manufacturer has to describe a procedure risk based and appropriate for his reusable device of cleaning, disinfection and/or sterilization respectively. The procedure has to be described in the instructions for use and the efficacy has to be shown by validation.
The Webinar will present an overview how to proceed in regard to classification, the choice of appropriate reprocessing procedures and description in the IFU. The presenters will show how to develop the testing strategy and the respective validation studies.
Topics:
- Do I meet (new) requirements for reprocessing of MDR and FDA? Challenges and Pitfalls.
- Is my reprocessing procedure and description in the IFU appropriate and compliant with actual requirements?
- How to develop a testing strategy for the validation of the reprocessing procedure?
- What do I have to consider before starting validation studies?
- Workflow for cleaning, disinfection and sterilization testing and new requirements e.g. AAMI ST98
At the end of the webinar there is going to be a live Q&A Session.
This webinar is presented by Anja Friedrich, Head of Consulting.
Two sessions are offered for this event:
Session in GERMAN, 11.05.23., 11:00-12:15 CET
Session in ENGLISH, 11.05.23., 16:00-17:15 CET
Who should attend?
The event is aimed at anyone involved with reprocessable medical devices.
Speaker:
Anja Friedrich is the head of the Eurofins Medical Device Consulting Team and has more than 25 years of experience in the field of biological safety of medical devices. She herself has set up and performed microbiological studies on medical devices under ISO 17025 and GLP in the laboratory for many years. Specifically, she also supervised validations of reprocessing procedures and has worked on biocompatibility for many years, as well as gaining extensive knowledge of regulatory background and testing strategies through committee work and client projects. Since May 2020, she has been leading the independent Eurofins Consulting company in Munich with a team of experts providing advice on the regulatory environment and biosafety of medical devices.
Marita Gleinser has been responsible for the microbiological testing of medicinal products and medical devices for several years as Head of the Microbiology Department at Eurofins BioPharma Product Testing Munich GmbH. In this role, she has gained extensive experience in the evaluation of cleaning, disinfection and sterilization procedures for reusable medical devices. In addition, she is active as a member of the standardization committee "Sterilization and Reprocessing of Medical Devices".
