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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
      • Software
      • Artificial Intelligence
      • Cybersecurity
      • Usability and Human Factors Engineering
      • Clinical
        • Evaluation
          • Appendix
            • CV-Ana Vidal
            • CV-Antonio Martorrel
            • CV-Jordi Barrachina
            • CV-Saray Ugidos
            • Declaration of Interests-Ana Vidal
            • Declaration of Interests-Antonio Martorrel
            • Declaration of Interests-Jordi Barrachina
            • Declaration of Interests-Saray Ugidos
          • R-TF-015-001 Clinical Evaluation Plan
          • R-TF-015-003 Clinical Evaluation Report
          • R-TF-015-011 State of the Art Legit.Health Plus
        • Investigation
        • R-TF-015-008 Clinical development plan
      • Commissioning
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Clinical
  • Evaluation
  • Appendix
  • Declaration of Interests-Saray Ugidos

Declaration of Interests

Expert Information​

Name: Saray Ugidos
Date: **___**

Declaration​

I, Saray Ugidos, 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 financial interests in Legit.Health or any competing organizations 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.

Signature​

**Signature:

**Date:___

**Place:

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Declaration of Interests-Jordi Barrachina
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R-TF-015-001 Clinical Evaluation Plan
  • Expert Information
  • Declaration
    • Financial Interests
    • Professional Independence
    • Compliance
  • Signature
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)