AstraCon

medical devices

About

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.

Technologies

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Keywords

family-owned business qms iso 13485 udi-di declaration of conformity quality management system regulatory data model legal services regulatory guidance for smes medical devices risk management regulatory affairs mdr compliance eu market access product classification medical device regulation eu authorized representative regulatory training regulatory consulting significant change management innovation in medical regulation strategic regulatory support b2b other scientific and technical consulting services digitalization in medical devices regulatory process optimization regulatory documentation notified bodies european market entry regulatory strategy for startups ivdr mdr compliance

Location

1 Am Hirschgarten, Bernried am Starnberger See, Bayern, Germany, 82347

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