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Compliant Stents

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Get your stents and implants in compliance with relevant regulations.

Stents and other medical implants come into intimate contact with the human body, sometimes over long periods of time or permanently. As such, they are subject to strict regulations regarding their safety. If you are a manufacturer of stents or implants and want to market them in the EU, you will need to apply for a CE Mark certificate. 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 a medical device product, including physicochemical, morphological characteristics, and topographical characterization of constituent materials.

SAXOCON has the expertise to help you get your stents and implants compliant and certified for sale in the EU.

Read about our services here.