Launching a medical device requires solid proof of safety and performance. At DeSia, we help you prepare clinical evaluation documents that meet international regulatory standards.
What We Offer
- Preparation of Clinical Evaluation Plans and Reports (CEP/CER)
- Literature review and data analysis
- Equivalence assessment with similar devices
- Integration with risk management and instructions for use
- Support during submissions to Notified Bodies or authorities
We ensure that your documentation remains aligned with current regulations and supports your device throughout its entire lifecycle.
Do you need help with your clinical evaluation? Book your complimentary initial consultation.
