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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 Martorrell
            • CV-Jordi Barrachina
            • CV-Saray Ugidos
            • Declaration of Interests-Ana Vidal
            • Declaration of Interests-Antonio Martorell
            • 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
  • Legit.Health Utilities
  • 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-Ana Vidal

Curriculum Vitae

Personal Information​

Name: Ana Vidal Quílez
Professional Title: QA/RA Consultant in MD&IVD, Clinical specialist / Medical writing
Current Position: QA/RA Consultant
Institution/Organization: CMG MedDEV
Email: ana.vidal@cmgmeddev.com
Phone: +34 664 537 184

Professional Qualifications​

Medical/Scientific Degree(s)​

  • Degree: Master's Degree in Advanced Therapies and Biotechnology
    Institution: Francisco de Vitoria University
    Year: 2020
    Specialization: Advanced Therapies and Biotechnology

  • Degree: Master's Degree in Pharmaceutical Industry
    Institution: CESIF
    Year: 2020
    Specialization: Pharmaceutical Industry

  • Degree: Material's engineering with specialization in Biomaterials
    Institution: Technical University of Madrid
    Year: 2018
    Specialization: Biomaterials

Additional Qualifications and Certifications​

  • GCP Certification: Yes (ICH Good Clinical Practice E6 (R2) e-learning course) - Date: 2022
  • Other Relevant Certifications: - In-Depth ISO 14155:2020 (March 2023)
    • IMO REQUISITOS DEL REGLAMENTO (UE) 2017/746 RELATIVOS A LOS PRODUCTOS SANITARIOS PARA DIAGNÓSTICO IN VITRO (2024)

MDR Annex XIV Compliance - Qualifications of Clinical Evaluators​

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

a) Appropriate scientific education:

  • Medical degree or relevant scientific qualification: Master's Degree in Advanced Therapies and Biotechnology; Material's engineering.
  • Field of specialization: Biotechnology, Biomaterials, Pharmaceutical Industry.

b) Training and experience in clinical research methodology:

  • Years of experience in clinical research: Experience in clinical specialist roles and medical writing since at least 2022; biomedical research since 2017.
  • Experience in critical assessment of literature: Authored over 30 Clinical Evaluation Reports (CERs) and Clinical Development Plans (CDPs).
  • Training in evidence-based medicine: ICH Good Clinical Practice E6 (R2) training; In-Depth ISO 14155:2020 course.

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

  • Clinical experience in relevant therapeutic area: Experience with dental implants, sterile wound spray solutions, and antibodies.
  • Understanding of device technology: Experience with medical device software, Class C IVDs, and Class I, II, and III devices.
  • Knowledge of intended use and clinical performance: Medical writing of clinical evaluations and CDPs; biological evaluations.

d) Understanding of regulatory requirements:

  • MDR 2017/745 Annex XIV requirements: QA/RA Consultant specialized in MDR & IVDR.
  • MEDDEV 2.7/1 Rev. 4 guidelines: Authored over 30 CERs.
  • Harmonized standards (ISO 14155, ISO 14971): Completed In-Depth ISO 14155:2020 course; performed risk management/assessments adhering to ISO 14971 standards.

Professional Experience​

Current Position​

Position: QA/RA Consultant
Institution: CMG MedDEV
Duration: Feb 2022 - Present
Key Responsibilities: - Medical Writing of over 30 Clinical Evaluation Reports (CERs) and Clinical Development Plans (CDPs) for software, dental implants, and wound spray.

  • Developing and compiling Technical Documentation for over 20 IVD devices.
  • Assisting in Biological Evaluations (BEP and BERS).
  • Developing SOPs for QMS in compliance with ISO 13485.
  • Guiding CE certification roadmaps and performing Risk Assessments (FMEA) in line with ISO 14971.

Previous Relevant Positions​

Position: Regulatory Affairs Technician
Institution: Laboratorios ROVI
Duration: Sep 2019 - Feb 2022
Key Responsibilities: - Provided post-market support for Class I, II, and III medical devices.

  • Managed manufacturing license renewals in compliance with local/EU regulations.
  • Registered Economic Operators and devices in EUDAMED.
  • Assisted with CE marking and ISO 13485 annual audits.

Position: Biomedical Researcher
Institution: PharmaMar
Duration: Oct 2017 - May 2018
Key Responsibilities: Production of Silk Fibroin Hydrogels for controlled drug delivery.

Clinical Evaluation and Research Experience​

Experience with Medical Devices​

  • Years of experience in medical device evaluation: Approximately 5 years in regulatory affairs and consultancy (2019-Present).
  • Types of devices evaluated: Software, dental implants, sterile wound spray solutions; Class I, II, and III medical devices; IVD devices (including antibodies and Class C IVD).
  • Regulatory experience (MDR, FDA, etc.): MDR, IVDR; Local and EU regulations; CE certification.

Clinical Research Experience​

  • Number of clinical studies participated: Not specified, but attended "CSMD 2023. Clinical studies with Medical Devices and IVDs".
  • Role in studies (PI, Sub-I, Evaluator): Clinical specialist / Medical writer.
  • Therapeutic areas: Dental, wound care, diagnostics.
  • Experience with CE marking processes: Guided the roadmap to CE certification; assisted with CE marking audits.

Expertise Relevant to This Evaluation​

Technical Expertise​

  • Dermatology/Medical imaging: Experience with sterile wound spray solutions (Dermatology/Wound Care).
  • Clinical assessment methodologies: Medical Writing of CERs and CDPs; Biological Evaluations.

Regulatory Knowledge​

  • MDR 2017/745: Specialized in MDR.
  • MEDDEV 2.7/1 Rev. 4: Experience authoring CERs.
  • ISO 14155 (GCP): In-Depth ISO 14155:2020 course completed.
  • Other relevant standards: ISO 13485 (QMS); ISO 14971 (Risk Management); IVDR (EU 2017/746).

Languages​

  • Spanish: Native
  • English: Fluent/Advanced (Cambridge Advanced Certificate in English, 2019)
  • French: Intermediate

Declaration​

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

Name
Ana Vidal Quílez
Place
Madrid (Spain)
Digital Signature
[ Place Digital Signature Here ]{{Sig_es_:signer:signature}}
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CV-Antonio Martorrell
  • 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
  • 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.)