Medical Device Disinfection Validation

We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.

We offer testing services to ensure the disinfection instructions outlined in your Instructions for Use (IFU) have been fully validate. As outlined in the ISO 17664 Processing of health care products: Information to be provided by the medical device manufacturer for the processing of medical devices
(part 1 Critical and semi-critical medical devices, and part 2 Non-critical medical devices), all Medical Devices manufactures are responsible to provide instruction of use when reprocessing of the device is intended. These instruction shall be fully validated to ensure safety of the device. Both manual and automated (Washer disinfector) processes shall be validated as per ISO 17664.

Medical Device Cleaning – Everything You Need to Know

In order to gauge the most accurate representation of the cleaning procedure, the validation experiments require the test device t...

Reprocessing Orthopaedic Medical Devices: Everything You Need to Know

Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients such as orthopae...

FDA Validation Requirements for Reusable Medical Devices: 21 CFR 801.5

FDA Validation Requirements for Reusable Medical Devices: guidance on the requirements and criteria for validation data