Medical Device Sterilisation Validation

We validate your medical device sterilisation instructions, as detailed in your IFU, which can be moist heat, low temperature hydrogen peroxide or other process.

We offer testing services to ensure the sterilisation instructions outlined in your Instructions for Use (IFU) have been fully validated. 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.

Technical file requirements for Class Ir: Everything you need to know

MDR requires a clear, organized, searchable, and unambiguous technical file presentation

Medical Device Manual Cleaning: Everything You Need to Know

According to ISO 17664, manufacturers must provide comprehensive information on cleaning, disinfection, and sterilisation processe...

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