Safe Reusable Medical Devices
Manufacturers of reusable medical devices must provide validated reprocessing instructions in their instructions for use of each device. Validation studies of cleaning, disinfection, and sterilisation procedures are essential to ensure the safety of reusable medical devices, as these studies demonstrate that the device can be properly cleaned and reprocessed between patients. The safety aspects of reprocessing medical devices include e.g., the reduction or removal of pathogenic microorganisms, the removal of contamination, and the potential toxicity of cleaning agents. Additionally, it is important to not cause damage to the construction or function of the device, which may also introduce patient hazards.
SAXOCON provides you with everything you need to plan, test, and document reprocessing validation studies of your reusable medical device, including:
- The selection of construction materials suitable for reusable medical devices
- Ensuring compliance with relevant guidelines such as AAMI TIR12 and ISO 17665
- The selection of appropriate laboratories
- Monitoring and evaluation of validation studies
Why choose us?
SAXOCON services for medical device manufacturers give you access to:
- A multidisciplinary team of highly skilled microbiologists, toxicologists and material scientists
- High-level experience in state-of-the-art reprocessing evaluations according to international standards and regional regulatory guidelines
- A reprocessing strategy designed by an independent third party that complies with applied standards and guidelines
SAXOCON compiles all relevant information and recommendations in a short statement
CE MArk certificate
Certify your products for sale in the EU.
Properly evaluate your materials.
Stay ISO 13485 and 14971 compliant.
PMT analysis for ISO 10993-19 compliance.