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EU Company specialising in EU Medical Device Regulatory Compliance

Enabling compliance with EU Regulations for medical and in vitro diagnostic devices.

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Our services at a glance

Authorised representative

EC REP for non-EU medical device companies.

Technical documentation

MDR- or IVDR-compliant technical files for your products.

Clinical evaluation

Clinical evaluation for any classes and types of medical devices/IVDs.


Person Responsible for Regulatory Compliance under MDR and IVDR.

Risk management

Robust risk management processes tailored to your products.

Notified bodies

Communication with NBs throughout the regulatory process.


Tailored solutions to address QMS non-compliance issues.

Postmarket surveillance

Systems for monitoring safety and performance of medical devices.

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360° services around the CE-marking

We offer a complete range of solutions that cover every aspect of the CE-marking process. From developing compliant technical documentation to serving as your authorised representative, we ensure compliance with European regulations.

Both MDR and IVDR covered

We offer services that cover both the Medical Device Regulation and the In Vitro Diagnostic Regulation.Our solutions ensure that you receive expert guidance and support for compliance with both MDR and IVDR requirements.

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Our solutions simplify your regulatory effort

With our solutions, you can save time, reduce administrative burden, and focus on what matters most – developing and delivering exceptional medical devices.

Send us an email:

Or use the contact form below