Germany Market Entry for CE-marked devices — from certification to commercial launch (AR/PRRC, EUDAMED, labeling, reimbursement)
14.09.2023 Germany Market Entry for CE-marked devices — from certification to commercial launch (AR/PRRC, EUDAMED, labeling, reimbursement) It is not always clear if a product is a medical device, a medicinal product, or something else and if it is a medical devices, what risk class. We help you define your product and its optimal route to compliance, guide you through the certification process, and assist in your entrance into the European market. contact us Back to services
EU AI Act Readiness for medical AI & SaMD — provider/deployer classification, Articles 9, 10, 13–15 obligations
19.08.2023 EU AI Act Readiness for medical AI & SaMD — provider/deployer classification, Articles 9, 10, 13–15 obligations Do you need help setting up the technical documentation or have doubts about your strategy to demonstrate the safety and efficiency of the device? We have the expertise to support you with all your questions and dilemmas and prepare you for the scrutiny by notified bodies or authorities. contact us Back to services
Regulatory Due Diligence for investors — de-risk MDR/IVDR & AI Act exposure before you invest
19.08.2023 Regulatory Due Diligence for investors — de-risk MDR/IVDR & AI Act exposure before you invest Tailored to the destination market healthcare system is essential for your success. We can help you adjust your strategy to the European market reality. contact us Back to services