AstraCon

AstraCon is a family-owned strategic regulatory consulting company based in Germany, serving medical device and in vitro diagnostic (IVD) companies globally. With offices in cities like Berlin, Munich, and Tübingen, AstraCon specializes in helping clients navigate European Union regulations, including the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The company offers a range of services, including regulatory consulting, acting as a European Authorized Representative, and assisting with submission strategies for performance studies. AstraCon also supports clients in creating and reviewing technical documentation to ensure compliance with MDR and IVDR. Additionally, they provide Quality Management System (QMS) setup assistance and free online tools to simplify compliance tasks, such as generating Declarations of Conformity and risk classification. AstraCon's clients include a diverse array of medical device and IVD manufacturers, from startups to established corporations, all seeking reliable support for regulatory compliance in the European market.

• Employees3
• Founded2013