No compromises. Period.
Odyssey is ISO 13485:2003 certified for the manufacture of ophthalmic and orthopaedic devices, and FDA registered for production of Class II devices.
Over the past decade, Odyssey has developed a comprehensive Quality Control System specific to the manufacture of medical implants. In addition, Quality Plans are developed for every single project to ensure that customer and regulatory needs are met or exceeded.
Quality Plans address documentation of all product requirements including risk management, production methods, process validations, inspection methods and statistical controls.
