Declaration of Interests
Expert Information
Name: Céline Fabre Date: ****__****
Declaration
I, Céline Fabre, hereby declare the following regarding my involvement in the clinical evaluation of medical devices manufactured by Legit.Health:
Financial Interests
I declare that I have no equity or ownership interests in Legit.Health or any competing organizations that could influence my professional judgment in conducting this clinical evaluation.
I disclose that I have been engaged under a paid consultancy agreement to perform an independent methodological and statistical evaluation of the clinical evidence gathered in support of the device's intended purpose. This engagement covers the assessment of study methodology, statistical validity, identification of evidence limitations, and the adequacy of the evidence base relative to the intended use. The compensation received is reasonable and proportionate to the work performed and does not create a conflict of interest.
Professional Independence
I confirm that:
- My professional judgment is not compromised by any conflict of interest
- I will conduct this clinical evaluation objectively and in accordance with MDR 2017/745 requirements
- I will follow the principles of Good Clinical Practice (GCP) and relevant European guidelines
- Any compensation received for this evaluation is reasonable and proportionate to the work performed
Compliance
This declaration is made in compliance with:
- Regulation (EU) 2017/745 (Medical Device Regulation - MDR)
- MEDDEV 2.7/1 Rev. 4 - Clinical Evaluation Guidelines
- ISO 14155:2020 - Good Clinical Practice
- ICH-GCP Guidelines (E6 R2)
I undertake to immediately disclose any changes to this declaration that may arise during the course of the clinical evaluation.
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