Medunion
Your Trusted Partner in Medical Device Compliance
Medunion offers end-to-end regulatory support for medical device manufacturers navigating the complex European market.
What we do
These supplementary services support you in complying with the Medical Device Regulation and implementing all regulatory requirements
EU-REP
We represent your company to European Competent Authorities, ensuring compliance with MDR/IVDR and maintaining regulatory documentation on your behalf.
EU Product Registration
We support device registration processes across EU member states, including Class I notifications and EUDAMED entries.
Technical File review
Full support in preparing and reviewing your technical files in accordance with Annex II and III of MDR/IVDR.
Clinical Support
Our CRO services help you plan, manage, and execute clinical investigations in the EU under MDR/IVDR, ensuring robust clinical evidence.
MDR Compliance
We provide tailored support to ensure your medical devices meet the requirements of the EU In Vitro Diagnostic Regulation (MDR 2017/745)
IVDR Compliance
We provide tailored support to ensure your IVD devices meet the requirements of the EU In Vitro Diagnostic Regulation (IVDR 2017/746)
An expert on your MedTech Path.
Streamlined Compliance for the European Market
Mission
To deliver high-quality regulatory, clinical, and compliance services that help medical device companies navigate complex regulations, accelerate market entry, and ensure patient safety across borders.
Vision
To be a trusted partner for global medical device manufacturers seeking efficient, expert-driven access to the European and international markets.
Values
Integrity , Expertise , Collaboration, Accountability
Some Insights
The healthcare and life science industries are changing, and we have the breadth of expertise to help you evolve with them.