Enhancing Clinical Trial Integrity Through Comprehensive Audits for MDR/IVDR
DeSia offers specialized Clinical Trial Audit services designed to ensure the highest quality, accuracy, and reliability of data in your clinical trials, with a keen focus on adherence to the In Vitro Diagnostic Regulation (IVDR) 2017/746 for studies involving IVD medical devices. Our audits are conducted with an objective and independent approach, focusing on several key standards, regulations, and the additional rigor required for IVD clinical trials under the IVDR.
Key Areas of Our Audit Process:
- Adherence to Good Clinical Practices (GCP): We ensure that clinical trials, including those for IVDs, are conducted in compliance with GCP, an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials.
- Compliance with EN ISO 14155:2020: This standard relates to the clinical investigation of medical devices for human subjects. Our audits meticulously check for strict compliance with its guidelines, crucial for both conventional medical devices and IVDs under IVDR.
- Compliance with EN ISO 20916:2019: Specific to IVD studies, this standard sets out requirements for the quality and competence in the pre-examination processes for in vitro diagnostic examinations. Our audits include a thorough assessment to ensure full compliance with this IVD-specific standard.
- Meeting MDR/IVDR Requirements: We evaluate how well the trial meets the specific requirements of the MDR 2017/745 & IVDR 2017/746, focusing on the additional scrutiny and documentation necessary for Medical device (MD) / IVD clinical trials. This includes assessing the scientific validity, analytical performance, and, where applicable, clinical performance of the MD / IVD being studied.
- Meeting Local Regulatory Requirements: Our evaluations extend to the conformity of the trial with local and regional requirements, ensuring that the study aligns with the specific regulatory environment, including the nuances introduced by the IVDR in the European Union.
- Assessment of Protocol and SOP Adherence: Our team rigorously examines if the study follows the approved protocol and standard operating procedures (SOPs), including those enhanced by the IVDR for IVD clinical trials, to maintain the integrity and validity of the trial.
- Detailed Reporting: Following the audit, we provide a comprehensive report detailing our findings, including any IVDR-specific issues, and recommendations for ensuring compliance and enhancing trial integrity.
Certification of Audit Completion
Upon request, DeSia can issue a certificate to confirm that the clinical research, particularly involving IVD medical devices, has undergone a thorough audit according to both general and IVD-specific standards, including the IVDR 2017/746. This certificate serves as a testament to the study's adherence to high standards, regulatory compliance, and the special considerations required for IVD clinical trials.
By choosing DeSia for your Clinical Trial Audit needs, you ensure that your clinical research, especially when involving IVDs, is conducted under the highest standards of quality and regulatory compliance. This not only enhances the credibility and reliability of your trial outcomes but also ensures alignment with the stringent requirements of the IVDR, thereby facilitating smoother market access and patient safety.
