Skip to main content
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 Martorrell
            • 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
  • 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 Thesis Title: "Evaluation of Interindividual Variability in analgesic response to Tapentadol and Oxycodone/Naloxone: Impact of Pharmacogenetics and Sex differences". 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.
  • Medical Writing: Experience in writing scientific protocols, manuscripts, and regulatory documentation, more than 10 peer-reviewed publications.

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: Dermatology, medical devices, Bioengineering, Biomedical Research, Clinical Trials Management, Allergology and 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, clinical research methodology through PhD programs, supervisor of 3 doctoral theses.

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.
  • MEDDEV 2.7/1 Rev. 4 guidelines: Applied in clinical evaluation report preparation.
  • ISO 13485 guidelines: Understanding of quality management systems for medical devices.
  • 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 Investigator.
  • 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​

12 scientific papers published in peer-reviewed journals in biomedical research, pharmacogenomics, allergology, and pain management:

  1. Apellaniz-Ruiz M, Barrachina J, Castro-Sanchez P, et al. Status of the implementation of pharmacogenetics in clinical practice in Spain: from regional to national initiatives. Drug Metab Pers Ther. 2024 Nov 11;39(4):183-199. doi: 10.1515/dmpt-2024-0042

  2. Muriel J, Escorial M, Margarit C, Barrachina J, et al. Long-term deprescription in chronic pain and opioid use disorder patients: Pharmacogenetic and sex differences. Acta Pharm. 2023 Jun 12;73(2):227-241. doi: 10.2478/acph-2023-0018

  3. Barrachina J, Margarit C, Muriel J, López-Gil V, et al. Sex Differences in Oxycodone/Naloxone vs. Tapentadol in Chronic Non-Cancer Pain: An Observational Real-World Study. Biomedicines. 2022 Oct 2;10(10):2468. doi: 10.3390/biomedicines10102468

  4. Barrachina J, Margarit C, Muriel J, López-Gil S, et al. Oxycodone/naloxone versus tapentadol in real-world chronic non-cancer pain management: an observational and pharmacogenetic study. Sci Rep. 2022 Jun 16;12(1):10126. doi: 10.1038/s41598-022-13085-5

  5. Barrachina J, Margarit C, Andreu B, Zandonai T, et al. Therapeutic alliance impact on analgesic outcomes in a real-world clinical setting: An observational study. Acta Pharm. 2022 Oct 18;72(4):529-545. doi: 10.2478/acph-2022-0035

  6. Gonzalez-Delgado P, Anvari S, Barrachina J, Portillo ALJ, et al. Egg-induced adult food protein-induced enterocolitis syndrome: Clinical phenotypes, natural history and immunological characteristics. J Allergy Clin Immunol Pract. 2024 Jun;12(6):1657-1659. doi: 10.1016/j.jaip.2024.03.005

  7. Ballester P, Espadas C, Almenara S, Barrachina J, et al. CYP2D6 Genotype and Pharmacovigilance Impact on Autism Spectrum Disorder: A Naturalistic Study with Extreme Phenotype Analysis. Pharmaceuticals (Basel). 2023 Jul 3;16(7):954. doi: 10.3390/ph16070954

  8. Gonzalez-Delgado P, Anvari S, Jimenez AI, Gallego-Velez P, et al. Cytokine Variations After Positive Oral Food Challenges in Adult-Onset Food Protein-Induced Enterocolitis. Allergy. 2025 Oct;80(10):2882-2885. doi: 10.1111/all.16539

  9. Muriel J, Margarit C, Barrachina J, Ballester P, et al. Pharmacogenetics and prediction of adverse events in prescription opioid use disorder patients. Basic Clin Pharmacol Toxicol. 2019 Apr;124(4):439-448. doi: 10.1111/bcpt.13155

  10. Peiró AM, Grimby-Ekman A, Barrachina J, Escorial M, et al. Health-Related Quality of Life in Chronic Pain Treated With Tapentadol Versus Oxycodone/Naloxone and Its Determinants: A Real-World, Single-Center Retrospective Cohort Study in Spain. Value Health Reg Issues. 2024 Nov;44:101013. doi: 10.1016/j.vhri.2024.101013

  11. Muriel J, Barrachina J, Del Barco G, Carvajal C, et al. Impact of CYP2D6 genotype on opioid use disorder deprescription: an observational prospective study in chronic pain with sex-differences. Front Pharmacol. 2023 May 31;14:1200430. doi: 10.3389/fphar.2023.1200430

  12. Peiró AM, Barrachina J, Escorial M, Aguado I, et al. Using a Two-Steps Clustering and PCA Analysis for Stratified Chronic Non-Cancer Pain Care: A Retrospective Cross-Sectional Study. J Pain Res. 2025 Feb 11;18:673-684. doi: 10.2147/JPR.S490442

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.
  • Doctoral theses supervised: 3 theses as co-director.
  • Areas: pain management, pharmacogenetics, bioengineering, clinical research methodology.
  • Institutions: University of Alicante, Miguel Hernández University.

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.
  • ISO 13485: Understanding of quality management systems for medical devices.
  • 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
  • Valencian/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: ********__********

Previous
CV-Antonio Martorrell
Next
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.)