UNTERNEHMEN

Family enteprise

TURNING REGULATION INTO SUCCESS

ASTRACON - A FAMILY ENTEPRISE

We are a family-owned company and are specialized in strategic regulatory consulting for medical device and IVD companies, situated in Germany. Our customers are manufacturers, importers, EC representatives, suppliers, and distributors from all over the world. Generally, we show them how to use seemingly complicated and oppressive regulations to their advantage. To achieve this, we provide individual and practice-oriented assistance. If desired, we also lend a hand ourselves. Whether technical documentation, QMS implementation (ISO 13485) or strategic consulting for the regulatory future of your company:

We take care of your company and your devices with expert knowledge and passion.

Our Philosophy

Many stakeholders perceive regulations as a burden and an obstacle on the road to CE and market access. Escpecially start-ups and SME. But we can transform them into powerful tools, if we apply them in a smart and practical way. With this in mind, we use these tools to turn your regulatory burden into a driver for your success. Let us show you how it is done!

Our Approach

We are convinced that any failure in a company’s quality management system can lead to patient harm. Therefore, safety and risk-based approaches are the basis of our daily work. With that in mind, we show you how to apply them to the processes of your company, and also to every aspect of your medical device. Above all, this approach enables us to make the medical world for patients safer – step by step.

Our Team

Do you like to get to know us a little bit better? Then check out our team site!