Do you manufacture in-vitro diagnostic medical devices? If so, you will need a CE Mark certificate to market them in the EU. A CE certificate verifies the biosafety of your products and that they perform as intended. Regulations such as (EU) 2017/746 (IVDR) Annex I...
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...
Do you manufacture reusable medical devices? If so, your products are likely used in medical facilities around the world. In the EU, manufacturers wanting to sell reusable medical devices must ensure that their cleaning, disinfection, and sterilisation procedures are...
Are you a pharmaceutical manufacturer? Do you know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by the various regulatory agencies? SAXOCON has the expertise and services necessary to help you to...
Every day people are exposed to chemicals from a variety of sources such as food products, cosmetics, clothing, medical devices, and medicines. EU regulations set requirements for testing chemicals for their potential to cause harm, be it through DNA damage, cancer,...
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 or permanently. As such, they are subject to strict regulations regarding their safety....
