Ensuring the biosafety of your medical implants is necessary for getting them in compliance with relevant regulations.
Medical implants come into intimate contact with the human body for periods lasting from a few hours to permanently. As such, they are subject to strict regulations regarding their safety. Manufacturers of medical implants need to apply for a CE Mark certificate if they are to be sold and used in the EU. A CE certificate verifies that a product is safe and performs as intended. The ISO 10993-1 standard describes the requirements for evaluating and testing the biological safety of all constituent materials in a medical device product.
SAXOCON has the expertise to help you get your implants compliant and certified for sale in the EU.
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