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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
  • CV-Ana Vidal

Curriculum Vitae

Personal Information​

Name: Ana Vidal
Professional Title:
Current Position:
Institution/Organization:
Email:
Phone:
Date: ___


Professional Qualifications​

Medical/Scientific Degree(s)​

  • Degree:
    Institution:
    Year:
    Specialization:

Additional Qualifications and Certifications​

  • GCP Certification: [Yes/No] - Date:
  • Board Certification:
  • Professional Registration Number:
  • Other Relevant Certifications:

MDR Annex XIV Compliance - Qualifications of Clinical Evaluators​

As per MDR 2017/745 Annex XIV Section 1, I confirm the following qualifications:

a) Appropriate scientific education:

  • Medical degree or relevant scientific qualification:
  • Field of specialization:

b) Training and experience in clinical research methodology:

  • Years of experience in clinical research:
  • Experience in critical assessment of literature:
  • Training in evidence-based medicine:

c) Competence in the relevant medical field and knowledge of the device:

  • Clinical experience in relevant therapeutic area:
  • Understanding of device technology:
  • Knowledge of intended use and clinical performance:

d) Understanding of regulatory requirements:

  • MDR 2017/745 Annex XIV requirements:
  • MEDDEV 2.7/1 Rev. 4 guidelines:
  • Harmonized standards (ISO 14155, ISO 14971):

Professional Experience​

Current Position​

Position:
Institution:
Duration: [From - To/Present]
Key Responsibilities:

Previous Relevant Positions​

Position:
Institution:
Duration:
Key Responsibilities:


Clinical Evaluation and Research Experience​

Experience with Medical Devices​

  • Years of experience in medical device evaluation:
  • Types of devices evaluated:
  • Regulatory experience (MDR, FDA, etc.):

Clinical Research Experience​

  • Number of clinical studies participated:
  • Role in studies (PI, Sub-I, Evaluator):
  • Therapeutic areas:
  • Experience with CE marking processes:

Publications and Scientific Contributions​

Peer-Reviewed Publications​

  1. [Author list]. [Title]. [Journal]. [Year];Volume:[Pages]. DOI:
  2. [Author list]. [Title]. [Journal]. [Year];Volume:[Pages]. DOI:
  3. [Author list]. [Title]. [Journal]. [Year];Volume:[Pages]. DOI:

Conference Presentations​

  1. [Author list]. [Title]. [Conference name]. [Location]. [Year].
  2. [Author list]. [Title]. [Conference name]. [Location]. [Year].

Book Chapters/Reviews​

  1. [Author list]. [Title]. In: [Book title]. [Publisher]. [Year]. [Pages].

Expertise Relevant to This Evaluation​

Technical Expertise​

  • Dermatology/Medical imaging:
  • Artificial Intelligence/Machine Learning:
  • Clinical assessment methodologies:
  • Statistical analysis:

Regulatory Knowledge​

  • MDR 2017/745:
  • MEDDEV 2.7/1 Rev. 4:
  • ISO 14155 (GCP):
  • Other relevant standards:

Professional Memberships​

  • Organization: [Name] - Role: [Member/Fellow] - Since: [Year]
  • Organization: [Name] - Role: [Member/Fellow] - Since: [Year]
  • Organization: [Name] - Role: [Member/Fellow] - Since: [Year]

Languages​

  • [Language]: [Native/Fluent/Intermediate/Basic]
  • [Language]: [Native/Fluent/Intermediate/Basic]
  • [Language]: [Native/Fluent/Intermediate/Basic]

Declaration​

I declare that the information provided in this curriculum vitae is accurate and complete to the best of my knowledge.

Signature: ___

Date: ___

Place: ___

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CV-Antonio Martorrel
  • Personal Information
  • Professional Qualifications
    • Medical/Scientific Degree(s)
    • Additional Qualifications and Certifications
    • MDR Annex XIV Compliance - Qualifications of Clinical Evaluators
  • Professional Experience
    • Current Position
    • Previous Relevant Positions
  • Clinical Evaluation and Research Experience
    • Experience with Medical Devices
    • Clinical Research Experience
  • Publications and Scientific Contributions
    • Peer-Reviewed Publications
    • Conference Presentations
    • Book Chapters/Reviews
  • Expertise Relevant to This Evaluation
    • Technical Expertise
    • Regulatory Knowledge
  • Professional Memberships
  • Languages
  • Declaration
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.)