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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-Jordi Barrachina

Curriculum Vitae

Personal Information​

Name: Jordi Barrachina
Professional Title: Clinical Research Coordinator
Current Position: Clinical Research Coordinator
Institution/Organization: Legit.Health

Professional Qualifications​

Academic Degree(s)​

  • Degree: PhD in Bioengineering
    Institution: Miguel Hernández University
    Year: 2018-2023
    Qualification: Cum Laude
    Specialization: Biomedical Research, Clinical Trials, Allergology and Pain Management

  • Degree: Master in Bioengineering
    Institution: Miguel Hernández University
    Year: 2016-2017

  • Degree: Biology Degree
    Institution: Alicante University
    Year: 2012-2016

Additional Qualifications and Certifications​

  • GCP Certification: The Global Health Network
  • ICH Guidelines Training: International Conference on Harmonization (ICH)
  • Statistical Software: Proficient in statistical analysis software
  • REDcap: Design and validation of medical questionnaires
  • Laboratory Techniques: Extensive experience with biological sample collection and analysis

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: PhD in Bioengineering (Cum Laude, Miguel Hernández University, 2018-2023), Master in Bioengineering (Miguel Hernández University, 2016-2017), Biology Degree (Alicante University, 2012-2016)
  • Field of specialization: Bioengineering, Biomedical Research, Clinical Trials Management, Allergology, Pain Management

b) Training and experience in clinical research methodology:

  • Years of experience in clinical research: 8+ years (5+ years in biomedical research, 3+ years in clinical trials)
  • Experience in critical assessment of literature: Extensive experience demonstrated through 10+ scientific publications and doctoral thesis
  • Training in evidence-based medicine: GCP certified, ICH guidelines training, statistical analysis expertise, systematic literature review experience

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

  • Clinical experience in relevant therapeutic area: 8+ years in biomedical research with focus on allergology and pain management; current role in medical device clinical validation
  • Understanding of device technology: Deep knowledge of medical device development, validation processes, and digital health technologies
  • Knowledge of intended use and clinical performance: Direct experience in clinical protocol writing, data collection, and clinical validation management

d) Understanding of regulatory requirements:

  • MDR 2017/745 requirements: Practical application in medical device regulation and clinical validation
  • ISO 14155 guidelines: Applied in clinical trial management and protocol development
  • GCP Guidelines: Certified and applied throughout clinical trial coordination
  • ICH Guidelines: Formal training and practical implementation

Professional Experience​

Previous Relevant Positions​

Position: Project Manager & Clinical Monitoring
Institution: Alicante Institute of Health and Biomedical Research
Duration: October 2021 - November 2023
Key Responsibilities:

  • Management of research projects of the Allergology Department
  • Coordination of clinical trials of the Pain and Allergology Units following GCP guidelines
  • Contact with patients and coordination of medical staff
  • Writing of scientific documentation and clinical protocols
  • Contact with study sponsors
  • Management of clinical data and laboratory techniques
  • Database management using REDcap

Position: Postdoctoral Researcher
Institution: Alicante General University Hospital (Alicante and Elche)
Duration: 2018 - November 2023
Key Responsibilities:

  • Design and management of research projects
  • Data collection during medical visits
  • Writing of scientific papers and oral communications
  • Collection and storage of biological samples (saliva, blood, mucosa)
  • Design and validation of questionnaires
  • Statistical analysis of research data
  • Supervision of research team members

Clinical Evaluation and Research Experience​

Experience with Medical Devices​

  • Years of experience in medical device evaluation: 2+ years (2023-Present)
  • Types of devices evaluated: Digital health solutions, AI-based diagnostic tools, dermatology medical devices
  • Regulatory experience (MDR, FDA, etc.): Extensive experience with MDR 2017/745, ISO 14155 clinical investigation standards, regulatory documentation management

Clinical Research Experience​

  • Number of clinical studies managed: Multiple clinical trials and research projects over 8+ years
  • Role in studies: Clinical Research Coordinator, Project Manager, Clinical Monitor, Principal Researcher
  • Therapeutic areas: Allergology, Pain Management, Dermatology, Digital Health
  • Experience with CE marking processes: Direct involvement in clinical validation protocols for medical device CE marking, regulatory documentation preparation

Publications and Scientific Contributions​

Peer-Reviewed Publications​

  • 10+ scientific papers published in peer-reviewed journals in the fields of biomedical research, allergology, and pain management
  • Publications available upon request

Conference Presentations​

  • Multiple oral communications at international conferences
  • Presentation of research findings in biomedical and clinical research settings

Doctoral Thesis​

  • Completed doctoral thesis in Biomedical Sciences
  • Focus on clinical research methodology and biomedical applications

Expertise Relevant to This Evaluation​

Technical Expertise​

  • Clinical Research Methodology: 8+ years designing and managing clinical research projects
  • Medical Writing: Extensive experience writing scientific protocols, manuscripts, and regulatory documentation
  • Statistical Analysis: Proficient in statistical software and data analysis
  • Team Management: Proven ability to coordinate medical staff and manage research teams
  • Laboratory Techniques: Extensive experience with biological sample collection and analysis
  • Database Management: REDcap expertise, design and validation of medical questionnaires
  • Medical Device Validation: Clinical protocol development and validation study coordination

Regulatory Knowledge​

  • MDR 2017/745: Practical application in medical device clinical validation
  • ISO 14155: Clinical investigation standards applied in trial management
  • GCP Guidelines: Certified and extensively applied in clinical trial coordination
  • ICH Guidelines: Formal training and implementation in clinical research
  • MEDDEV 2.7/1 Rev. 4: Knowledge applied in clinical evaluation processes

Languages​

  • Spanish: Native
  • Catalan: Native
  • English: Fluent
  • German: Intermediate

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-Saray Ugidos
  • 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
    • Peer-Reviewed Publications
    • Conference Presentations
    • Doctoral Thesis
  • Expertise Relevant to This Evaluation
    • Technical Expertise
    • Regulatory Knowledge
  • 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.)