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Regulatory reporting requirements for medical device approval are rapidly changing. This is especially relevant if your product is marketed globally.

Keeping up to speed with the very latest country specific legal requirements is one of the greatest and most time-consuming challenges for the industry. 

In fact it is one of the highest risks.


Regulatory Intelligence

Our goal is to make the difference: We offer support for the phamaceutical and medtech industry that goes far beyond standard solutions having recruited the best staff and working hand in hand with you to determine and address your project specific needs and to meet your expectations.


Developed for you by our team of experts, the regulatory intelligence solution Daedalus®, provides you with global regulatory requirements for medical devices and in vitro diagnostics.

With the Daedalus online database, you have 24/7 access to up-to-date country-specific regulatory information for the markets in which you operate.

IT Security Consulting

IT security is essential in today's world. With the right implementation, you are protected against cyber attacks and other online threats. Your digital know-how remains intact and you save time and money.

Software Development

Customised software has a lot of key benefits for you. Optimised digital processes and administrative procedures create efficiency and security. Enhancements and changes ensure that your developing business processes are always taken into account.


Regulatory Compliance

Inspection Readiness

Reduction of Workload

Faster Market Access

Profit Increase

Excellent Client Service

   Thanks to RegIntA, we always stay up-to-date with the ever-changing requirements of medical device regulations. The systematic tracking of different websites helps us to react quickly to changes. 

We appreciate the uncomplicated and good cooperation with RegIntA and the professionalism with which the team supports us in all regulatory questions. In recent years, RegIntA has become an integral part of our daily work.

Katharina Schrick, Head of Regulatory Affairs, TRACOE medical GmbH



RegIntA GmbH

Nieder-Rußbacher-Str. 1

63674 Altenstadt



Executive Director:

Katrin Rosen

Ust.-ID: DE 317189811

HRB 8759

Amtsgericht Friedberg

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