At Desia, we provide comprehensive clinical affairs services to support your medical and in vitro diagnostic devices across global regulatory frameworks. Our expertise spans the full lifecycle, from development to post-market, ensuring your clinical and performance evidence complies with international requirements.
We prepare and maintain clinical evaluation plans and reports for medical devices and performance evaluation reports for in vitro diagnostic devices in accordance with recognized standards and regulations, including EU MDR/IVDR, FDA, TGA, and others. We also design and manage post-market clinical follow-up/post market performance follow-up activities to sustain clinical/ performance evidence over time.
When clinical investigations or clinical performance studies are required, we manage the entire process from protocol development and ethics committee submissions to site coordination, data collection, and reporting, ensuring full alignment with good clinical practice, ISO 14155, ISO 20916 and local regulatory expectations.
With Desia as your partner, you gain a globally aligned, scientifically rigorous, and regulatorily sound clinical strategy tailored to your device and your markets.
