If you want to sell your medical devices in Europe and your company does not have a physical location within the EU, the Medical Device Directive requires for the CE marking of your products that you appoint an Authorized Representative (AR) based within the EU. The European AR serves as intermediate contact link between you and the national Competent Authority (typically the Ministries of Health).
Astaris Medtech as independent AR is focussed on regulatory affairs and can offer advice and services unconnected to sales and marketing interests of your local distributor. As your AR Astaris Medtech offers assistance with national device registration procedures as required and with incident and Field Safety Correcting Actions (FSCA) reporting.