For re-processable medical devices, manufacturers must provide reprocessing instructions describing cleaning, disinfection and sterilization and prove that these procedures are valid.
In addition to the validity of the process, the safety of the product after reprocessing and over the entire life cycle must also be demonstrated.
Watch our webinar to gain insight into:
- Regulatory requirements EU/FDA
- Considerations for the instruction for use (IFU) and the validation study
- Validation performance for cleaning, disinfection and sterilization of reusable medical devices
- Reprocessing over life cycle and considerations
Jörg-Peter Gütlein, UL Laboratory Team Lead
Recorded on Sept. 16, 2021