Strategic guidance in Regulatory Affairs & Quality Assurance

We support and guide you towards the most efficient, safe and optimal compliance strategy for your medical device and in-vitro diagnostic devices.


Our focus is to shorten time-to-market and make the regulatory process as predictable and reliable as possible.


Our Offer

We offer expertise and guidance within Regulatory Affairs and Quality Assurance exclusively for medical devices and IVD.

Our dedicated team of experts support you with all question and aspects of Regulatory Affairs and Quality Assurance. Together, we find and put together the best solution for you and your device. And it doesn’t matter if you are a large corporation, a fast-moving start-up or a person with an idea – we guide you.

Regulatory Affairs

The Medical device regulatory landscape is hard to navigate as it demands a compliance process that follows the ever-changing framework. As experienced specialists, we support and guide you with the strategies and execution plans needed. Our focus is to find the most efficient and optimal solution for you.


Quality Assurance

Always stay one step ahead with a smart Quality Management System in place. We support you in every step – from GAP-analysis, ISO-13485 compliance, internal audits to setting up and configuring the system. If needed, we can be your Quality Assurance Manager and take care of all QMS related activities for you.


Other Services

Regulatory affairs and quality assurance are our primary area of expertise. However, we also offer other consultancy services supporting the process of medical compliance. E.g., we can be your EU Authorized Representative or act as the Person Responsible for your Regulatory Compliance (PRRC).


Are you ready for The MDR-transfer?

Make sure your device complies to the new EU Medical Device Regulation, MDR 2017/745. The deadline for the application is set to 26th of May 2021. Let us help you – you will have a smooth transition to the new regulation.


This is

We are a flexible expert partner supporting our clients with all aspect of Regulatory Affairs and Quality Assurance.

Our focus is to assist our clients and ensure that useful medical devices and IVD’s reach the market as fast and predictable as possible. There is no solution that is suitable for all and we are dedicated to establish the best possible compliance strategy for all our clients based on their needs.  All our advice is based on our vast experience and membership in technical committees and global regulatory forums.

We believe that teamwork, commitment and flexibility is the key to success.

News & Whitepapers

Our ecosystem for full-service medical device compliance

Together with Devicia, LimulusBio, Lea Reg and Kickfile, we support all your needs, everywhere, every time. Irrespective if it relates to strategy, Quality Assurance, Regulatory Affairs, Clinical Affairs, Biocompatibility, UK representation or EU Authorized Representative. We got you.


Devicia is a full-service partner offering regulatory and clinical expertise for medical devices. As members of the technical committees’ writing medical device standards, Devicia are always up-to-date with the latest news and regulations and take part in the process of decision making.


Limulus Bio

Limulus Bio is your partner in the field of Biocompatibility & Toxicology for medical devices and support you with Risk Assessment Strategies, material guidance and Biological Evaluations.



Kickfile aims to simplify the process of compliance by providing a cloud-based document system supporting clinical evaluations and investigations.