Rosapeak Advisors

EC representative

We provide Authorized Representative services for Medical Device Manufacturers based in the USA, UK, and Switzerland. Their service includes reviewing and ensuring product compliance with EU regulations, such as the MDR and IVDR, by implementing a mandate contract, providing support for insurance requirements, registering devices with national Competent Authorities, maintaining technical documentation, performing audits, and coordinating incident resolution and communication with EU authorities. Please contact us.