Declaration of Interests
Expert Information
Name: Jordi Barrachina Date: ****__****
Declaration
I, Jordi Barrachina, hereby declare the following regarding my involvement in the clinical evaluation of medical devices manufactured by Legit.Health:
Financial Interests
I declare that I am the Clinical Research Coordinator at Legit.Health. I confirm that my professional judgment is not compromised by this relationship and I have no other financial interests that could influence my professional judgment in conducting this clinical evaluation.
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.
Name
Jordi Barrachina
Role
Clinical Research Coordinator
Place
Alicante (Spain)
Digital Signature
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