OUR MISSION

TURNING REGULATION INTO Success

Regulations are often perceived as a burden and an obstacle on the way to CE and market access. We show you how to integrate regulation into your daily operations. We are convinced that every failure in the quality management system of a company can translate into death of a patient.


Patient safety and risk based approaches are the basis of our daily work.

Strategic regulatory consulting for MedTech and IVD companies

Engaging with AstraCon will future-proof your business. We follow your strategic goals with passion, having an eye on regulatory compliance.

The practical approach is key.

You have strategic questions?
We have practical answers.

Who will upgrade your clinical evaluation?
Who will take care of PMS and the necessary reporting?
When and how should CE and QM certification be adapted to the new regulations?  

Together we will find solutions for your individual questions and requirements.


"The moment people talk of
"implementing" instead of "doing,"
and of "finalizing" instead of "finishing,"
the organization is already
running a fever."

Peter Drucker