Stents and other medical implants are products that have a high level of contact with the human body. 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. This certificate verifies that the product is safe and performs as intended. The ISO 10993-1 standard prescribes a process for evaluating and testing the biological safety of a medical device product, including the physicochemical, morphological, and topographical characterization of materials.
SAXOCON has the necessary expertise to help you get your stents and implants compliant and certified for sale in the EU.