Critical Role of Clinical Research in Medical Device Development
In the dynamic field of medical device development, clinical research emerges as a cornerstone, indispensable for securing the approvals needed for market launch and conducting effective Post-Market Clinical Follow-up (PMCF). At DeSia, we acknowledge the vital and complex nature of this process. Our comprehensive service offering is designed to address every facet of Medical Device Clinical Research, with a team of specialists proficient in navigating medical device regulations, including the International Organization for Standardization (ISO) 14155, ISO 20916, the International Council for Harmonisation's Good Clinical Practice (ICH-GCP), and the Medical Device Regulation (MDR) 2017/745.
Our Enhanced Clinical Research Services Portfolio includes:
- Development and Documentation of Clinical Research Strategy: We create bespoke research strategies, ensuring alignment with your device's specific needs and compliance with ISO 14155 for clinical investigation, ISO 20916 for IVDs, alongside ICH-GCP and MDR standards. This approach guarantees that every phase of the research is meticulously planned and documented.
- Preparation for Ethics Committee and Competent Authority: Our team compiles all necessary documentation for submissions to Ethics Committees and the Competent Authority, mastering the complex preparation process with adherence to the rigorous requirements outlined by ISO 14155, ISO 20916, and the MDR.
- Ethics Committee Applications and Query Management: We efficiently manage applications and address any queries from Ethics Committees, facilitating a smooth approval process in strict accordance with ICH-GCP principles and MDR requirements.
- Competent Authority Study Presentations and Discussions: Our proactive engagement with Competent Authorities to discuss and present clinical research details ensures clarity, compliance, and approval, backed by our deep understanding of ISO 14155 and MDR regulations.
- Project Management: With a keen focus on efficiency and efficacy, our project management services oversee the entire clinical research trajectory, from initiation through to completion, ensuring compliance with ISO 14155, ISO 20916, ICH-GCP, and MDR standards.
- Statistical Evaluation: We perform comprehensive statistical analyses to affirm the scientific validity and reliability of the research data, in line with the stringent requirements of ISO 14155 and ICH-GCP guidelines.
- Final Clinical Research Report Preparation: Our experts compile a detailed final report that encapsulates all findings, conclusions, and data from the clinical study, ensuring it meets the high standards set by ISO 14155, ISO 20916, ICH-GCP, and MDR.
Embarking on Clinical Research with DeSia
At DeSia, we delve into the subtleties and complexities of medical device clinical research, offering you a partnership that guarantees precision, efficiency, and strict adherence to the highest regulatory standards. By choosing DeSia, you leverage a team dedicated to facilitating your medical device's successful study outcomes and seamless market entry, all in compliance with ISO 14155, ISO 20916, ICH-GCP, MDR and IVDR regulations.
For a custom-fit solution to your medical device clinical research needs, reach out to discuss how we can support you in navigating the path to market success. Whether you require full-service support or select services, DeSia is here to ensure your clinical research journey is seamless and compliant.
