Not sure how to find your way

to ISO 13485 certification, CE marking and market access?

AstraConsulting: Answers to your regulatory Questions

Understanding and acting efficiently on regulations like MDR and IVDR is often complicated. Like a mountain guide, our experts will guide you to the top of the regulatory mountain, according to your individual needs and skill sets. Particularly, they will answer all your questions in the best possible way and thereby help you find the most relaxing, safest, fastest, shortest or most instructive regulatory route. You can count on our answers to bring you closer to your goal – ISO 13485 certification or CE marking and market approval of your IVD or medical device.
Choose one of the following options!

One Question

You have pressing regulatory problems and need reliable answers? Ask a question for free. Our regulatory experts will answer you within 2 work days.

One Hour

We will meet via video conference and consult you on your most pressing regulatory problems and answer all your RA/QM-related questions.
The new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have had a huge impact on the MedTech industry with all its economic operators. In order to ease your burden, we offer strategic consulting to tackle important decisions, such as:
Additionally, we assist with the communication with national and international Competent Authorities, Notified Bodies and Expert Panels.



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