At DeSia, we understand that navigating the intricacies of Medical Device Clinical Evaluation, Clinical Research, and Performance Evaluation for in vitro Diagnostic Medical Devices demands a blend of speed, expertise, and experience. Recognized as the cornerstone of product development and post-market surveillance, clinical studies require careful planning and strategic execution to support efficacy and avoid costly repetitions.
Expertise at Every Step
Our team, comprised of specialists in Medical Devices and in vitro Diagnostic Devices, excels in traversing the complex landscape of laws and clinical research. We're committed to conducting scientifically robust Clinical Studies and crafting documentation designed for seamless legal approval.
- Comprehensive Support: We offer end-to-end assistance throughout the clinical research and evaluation process, encompassing clinical and legal regulations, product approvals, biostatistics, and data management.
- Core Principles: Our approach is anchored in:
- Data Protection: Safeguarding data integrity at every phase.
- Sustainable Solutions: Providing long-term, effective strategies.
- Knowledge Sharing: Facilitating professional exchange of information.
- Precision in Delivery: Ensuring accurate and timely project completion.
Tailored Services for Medical Devices:
- Clinical Evaluation Plan and Report (CEP&CER): Preparing thorough evaluation plans and reports, aligned with EU MDR 2017/745 and related MDCG guidelines.
- Post-Market Clinical Follow-up (PMCF): Strategizing and executing PMCF studies to corroborate ongoing compliance and safety.
Innovating for In Vitro Diagnostic Devices:
- Performance Evaluation: Offering a comprehensive suite of services for Performance Evaluation, including planning, reporting (PEP&PER), and Post-Market Performance Follow-Up (PMPF), tailored to meet specific needs.
- Global Reach Through Collaborations: Leveraging our international partnerships, we extend the scope of our services, enabling Clinical Studies to be conducted across various countries, adapting to global standards and diverse regulatory environments.
