General Medical Device Services
Timely materials screening and selection
SAXOCON can help you select and evaluate construction materials for their suitability to comply with all regulatory requirements for medical devices.
Ready-set-go safe to market
SAXOCON provides you with everything you need to plan, test, and document compliance with ISO 10993-1 so you can secure a CE Mark certificate and quickly get your medical device to market in the EU and beyond.
Manage change and stay safe
SAXOCON helps you evaluate the impact of design and manufacturing changes for compliance with the regulatory safety requirements found in ISO 13485 and 14971. Make sure that when changes are made you are still compliant.
Surface characterisation
SAXOCON provides analysis to get your medical devices through the physico-chemical, morphological, and topographical (PMT) characterisation in compliance with ISO 10993-19 as required for your CE certificate.