Your Strategic Partner in Medical Device Investigations & IVD Clinical Performance Investigations
Generate Robust Clinical Evidence for Global Market Access
Demonstrating the safety, performance and clinical benefit of your medical device is essential for MDR/IVDR compliance, CE marking and global commercialization.
With its fully integrated, end-to-end approach, DeSia delivers fast, reliable and audit-ready clinical evidence for your product. From strategy and ethics submissions to site management, data analysis and final reporting, we manage every step under one roof—accelerating your path to market.
Our Services
1. Clinical Strategy and Core Documentation
2. Regulatory Submissions, Clinical Operations and Project Management
3. Data Management, Statistics and Scientific Reporting
Why DeSia?
- MedTech-Focused Expertise
Exclusive focus on medical devices and IVDs ensures deep domain expertise.
- Integrated End-to-End Approach
Strategy → Submission → Operations → Analysis → Reporting
A seamless, fully integrated workflow under one roof.
- Global Regulatory Alignment
Processes aligned with MDR, IVDR, ISO 14155, ISO 20916, ISO 14971 and GCP.
- Efficiency, Transparency and Predictability
Cost-effective planning, clear timelines and proactive communication.
- Audit-Ready Outputs
All processes and documents are designed to meet Notified Body and authority expectations.
Let’s Elevate Your Clinical Evidence
Whether you need the right clinical strategy, want to accelerate CE marking or require PMCF data, DeSia is your trusted partner.
Book your complimentary initial consultation.