At DeSia, we offer clear and reliable support throughout your clinical and regulatory journey. From clinical evaluations, PMCF activities and clinical trial design to statistical analysis and reporting, we ensure every step is fully aligned with current regulatory expectations. We help you choose the right study design, plan effectively and manage documentation with precision. Our team has broad experience across various medical device types and has successfully supported many approvals by Notified Bodies and Competent Authorities.
We believe that with the right expertise and partner, even the most complex challenges can be solved through simple and effective solutions. Beyond clinical affairs, we provide expert consulting in quality systems, regulatory compliance, validation and technical documentation preparation. Our accredited laboratory offers testing services including stability, packaging integrity and transport simulation to verify the safety and robustness of your devices. We also guide usability studies and support biocompatibility strategies. With DeSia, you gain a reliable partner focused on clarity, compliance and results, helping you bring safe and effective devices to market.