WHY I SHOULD JOIN THE WEBINAR:
Reprocessing is a process carried out on a used device in order to allow its safe reuse including cleaning (removal of soil and contaminants), disinfection, sterilization (inactivation of microorganisms) and related procedures, as well as testing and restoring the technical and functional safety of the used device. Due to recent changes in medical device standards and regulations, manufacturers intending to market reusable devices must plan their testing strategy in advance, perform the required tests using state-of-the-art test methods, and evaluate all results in a biological risk assessment document. It is critical to consider proposed changes to AAMI/CDV-2 ST98 and EU MDR, as some changes will require a modified design for cleaning validation. To ensure all requirements are met, close cooperation between various experts, including engineers, analytical chemists, and toxicologists, is necessary.
- Expectations of regulatory authorities regarding the cleaning validation studies
- Details of the test approaches, focusing on the AAMI/CDV-2 ST98 standard and EU MDR
- A high-level overview of requirements for validation of disinfection and sterilization
- Common feedback from regulatory agencies
WHO SHOULD PARTICIPATE:
- Scientists responsible for research and development
- Product development
- Quality assurance
- Regulatory compliance.
EVENT KEY NOTE SPEAKER:
GLP Facility Manager of the Biocidal Products Division in Eurofins Biolab (Italy). Has a solid expertise on efficay assessment of disinfectants. A member of the European Committee CEN TC 216 that establishes standardized methods of test and requirements for the antimicrobial efficacy of chemical disinfectants and antiseptics
Senior Consultant at Eurofins Medical Devices Italy
** Israel Time Zone