Streamline your path to market
Clinical Support
Quality Assurance & Compliance
CRO Services Across Your Entire Clinical Journey
Bringing medical devices and diagnostic products to market requires navigating ever-changing regulatory landscapes and designing trials that are both efficient and effective. With deep expertise in global regulations and strategic development, we provide the guidance and support you need to unlock your product’s full potential.
Our Clinical Services
Medunion delivers comprehensive Contract Research Organization (CRO) support to fast-track your medical device development and approval. Our experienced team ensures every stage runs smoothly—with full regulatory compliance, operational efficiency, and reliable, high-quality outcomes.
- Design & Planning
- Regulatory Submissions
- Clinical Monitoring
- Data Management
- ISO 15189 Compliance
- Site Selection
- Project Management
- ERP
- Medical Writing
- Registration
Integrity
Offer others what you wish to receive yourself: support, kindness, loyalty, trust, patience, and understanding.
Trust
We offer a thorough understanding of the complex challenges faced by medical device and IVD developers
Flexibility
We hold ourselves to the standard of being flexible and adapting our services to meet each client’s specific needs.
Quality
We follow ISO 15189 as the international standard that specofies requirements for quality and competence in medical laboratories.
Ready to bring your MD/IVD to the EU?
Our experienced team is ready to guide you through the regulatory process, ensuring your product meets all applicable requirements with confidence and efficiency.
Avoid unnecessary delays—get in touch with us today and take the next step toward faster, compliant market access.
- Simplifying Regulatory Compliance for Medical Devices Across Europe.
