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QMSQMS
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-Saray Ugidos

Curriculum Vitae

Personal Information​

Name: Saray Ugidos Seman
Professional Title: Clinical & QA/RA Manager
Current Position: Clinical & QA/RA Manager
Institution/Organization: Legit.Health

Professional Qualifications​

Academic Degree(s)​

  • Degree: Bachelor in Economics
    Institution: University of La Laguna, Spain
    Year: 2005-2010
    Additional Studies: Erasmus Scholarship - Universidad de París Sud11 (2008-2009), Seneca Scholarship - Universidad de Granada (2010-2011)
  • HSE Engineer: Official Masters in Health and Safety HSE, Universidad Internacional de la Rioja - Year: 2011-2012
  • University Master QHSE: Integrated Management (Environment, Quality and Safety), Escuela Europea de Negocios - Year: 2011-2012

Additional Qualifications and Certifications​

  • Technical File Expert MDR: BSI - Year: 2023
  • Lead Auditor ISO 13485: BSI - Year: 2023
  • RAPS Certificate Regulatory Expert: - Year: 2023
  • Ophthalmic Assisting 101: IJCAHPO - Year: 2022
  • Safety Officer, MSST Safety Specialist: SUVA, Switzerland - Year: 2018
  • Quality Technician Certificate: Agencia Española de Calidad (AEC), Madrid - Year: 2012

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:

  • Relevant scientific qualification: Bachelor in Economics with specialized postgraduate training in QHSE Management and Regulatory Affairs
  • Field of specialization: Medical Device Regulation, Quality Management Systems (ISO 13485), Clinical and Regulatory Affairs

b) Training and experience in clinical research methodology:

  • Years of experience in clinical research: 5+ years in clinical affairs and regulatory management
  • Experience in critical assessment of literature: Extensive experience in clinical evaluation and literature review for medical device technical files
  • Training in evidence-based medicine: Clinical evaluation training through BSI MDR Technical File Expert certification and RAPS Regulatory Expert program

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

  • Clinical experience in relevant therapeutic area: 5+ years managing clinical trials and evaluations in Europe, specialized in medical devices including ophthalmic and digital health technologies
  • Understanding of device technology: Deep knowledge of medical device technical files, risk management (ISO 14971), and clinical evaluation procedures
  • Knowledge of intended use and clinical performance: Extensive experience coordinating technical file preparation and clinical evaluation reports for CE marking

d) Understanding of regulatory requirements:

  • MDR 2017/745 Annex XIV requirements: Certified Technical File Expert MDR by BSI (2023)
  • MEDDEV 2.7/1 Rev. 4 guidelines: Practical application in clinical evaluation report preparation
  • Harmonized standards (ISO 14155, ISO 13485, ISO 14971): Lead Auditor ISO 13485 certified, extensive implementation experience

Professional Experience​

Previous Relevant Positions​

Position: Freelancer - Clinical & QA/RA Manager
Institution: Independent Consultant
Duration: 2021 - Present
Key Responsibilities:

  • Technical file preparation for medical devices
  • Quality Affairs management (ISO 13485)
  • Regulatory Affairs (FDA and MDR)
  • Clinical Affairs management and coordination

Key Clients:

  • Aura Health (2024 - Present) - QA/RA Manager
  • DESKi (2023 - Present) - QA/RA Manager
  • SyrhaTech (2021 - Present) - QA Manager
  • ACORAI (2021 - 2023) - Clinical & QA/RA Manager

Position: Clinical and Regulatory Manager
Institution: Medevise
Duration: July 2021 - 2023
Key Responsibilities:

  • Coordinate technical file preparation
  • Develop and maintain SOPs following ISO 13485
  • Manage Quality activities (ISO 13485 Certification)
  • Support clients in Regulatory Affairs
  • Manage trial master file of clinical trials in Europe (CRO)
  • Manage regulatory submissions (Clinical)

Position: Quality and Regulatory Affairs Manager
Institution: Mikajaki
Duration: January 2020 - July 2021
Key Responsibilities:

  • Coordinate technical file preparation
  • Develop and maintain SOPs following ISO 13485
  • Manage Quality activities (ISO 13485 Certification)
  • Regulatory Affairs (EU)
  • Clinical Affairs (EU)

Position: Quality & MSST Specialist
Institution: Ensemble Hospitalier de la Cote Suisse
Duration: October 2018 - January 2020
Key Responsibilities:

  • Perform risk assessment and preventive action plans
  • Define the QHSE strategy
  • Manage Audits activities (ISO 9001, 14000, 45000 Certification)
  • Manage regulatory submissions (Clinical)

Position: Quality & MSST Safety Specialist for LS2 Project
Institution: CERN Switzerland
Duration: May 2016 - August 2018
Key Responsibilities:

  • Perform risk assessment and preventive action plans
  • Define the QHSE strategy and implementation
  • Manage Audits activities (ISO 9001, 14000, 45000 Certification)

Clinical Evaluation and Research Experience​

Experience with Medical Devices​

  • Years of experience in medical device evaluation: 5+ years (2020-Present)
  • Types of devices evaluated: Digital health solutions, ophthalmic devices, cardiovascular monitoring devices, AI-based diagnostic tools
  • Regulatory experience (MDR, FDA, etc.): Extensive experience with MDR 2017/745, FDA 510(k) pathways, technical file preparation, and CE marking processes

Clinical Research Experience​

  • Number of clinical studies managed: Multiple clinical trials and evaluations across Europe
  • Role in studies: Clinical Manager, CRO Manager, Trial Master File Management
  • Therapeutic areas: Ophthalmology, Cardiology, Digital Health, Dermatology (AI-based diagnostics)
  • Experience with CE marking processes: Lead role in multiple CE marking submissions, technical file coordination, and clinical evaluation report preparation

Publications and Scientific Contributions​

Technical Documentation​

  • Extensive experience in preparing Clinical Evaluation Reports (CERs) following MEDDEV 2.7/1 Rev. 4
  • Technical file preparation for multiple medical device manufacturers
  • Risk management documentation (ISO 14971)

Expertise Relevant to This Evaluation​

Technical Expertise​

  • Medical Device Regulation: MDR 2017/745, FDA regulations, ISO 13485, ISO 14971
  • Clinical Evaluation: Clinical Evaluation Report preparation, literature review, equivalence assessment
  • Quality Management Systems: ISO 13485 implementation and auditing (Lead Auditor certified)
  • Risk Management: ISO 14971 application in medical device development
  • Clinical Trial Management: Trial Master File management, CRO coordination, regulatory submissions

Regulatory Knowledge​

  • MDR 2017/745: Certified Technical File Expert (BSI, 2023)
  • MEDDEV 2.7/1 Rev. 4: Practical application in clinical evaluation
  • ISO 13485: Lead Auditor certified (BSI, 2023)
  • ISO 14155 (GCP): Clinical investigation standards
  • ISO 14971: Risk management for medical devices
  • RAPS Regulatory Affairs: Certified (2023)

Professional Memberships​

  • RAPS (Regulatory Affairs Professionals Society): Member - Regulatory Affairs Professional Certification

Languages​

  • Spanish: Native
  • French: Fluent
  • Italian: Fluent
  • English: Fluent

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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Declaration of Interests-Ana Vidal
  • Personal Information
  • Professional Qualifications
    • Academic Degree(s)
    • Additional Qualifications and Certifications
    • MDR Annex XIV Compliance - Qualifications of Clinical Evaluators
  • Professional Experience
    • Previous Relevant Positions
  • Clinical Evaluation and Research Experience
    • Experience with Medical Devices
    • Clinical Research Experience
  • Publications and Scientific Contributions
    • Technical Documentation
  • 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.)