At Lucideon, we’ll support you as you develop reusable medical devices and submit them for regulatory approval.

We offer:

• Process design and development for the reprocessing of a medical device
• Validation of the effectiveness of a reprocessing method (cleaning, disinfection and sterilization)
• Validation of the compatibility of a device with the method
• Choice and identification of appropriate soils and detergents.

In our ISO 17025 and cGMP-accredited laboratories, we work to AAMI TIR12:2010, Designing, testing and labelling reusable medical devices for reprocessing health care facilities: A guide for medical device manufacturers, and AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, guidance.

What makes us unique?

• Unlike other laboratories, we can perform both chemical and biological testing
• We have a world-leading surface science facility that provides cleaning validation through surface analysis
• We are not just a test lab – we are materials experts who focus on providing solutions to your challenges, e.g. when a product, process, method or cleaning protocol fails
• We have many years’ experience in cleaning validation and have a proprietary program, VALIDATA, that provides quantitative, on-going third party cleanliness validation.