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
- [Author list]. [Title]. [Journal]. [Year];Volume:[Pages]. DOI:
- [Author list]. [Title]. [Journal]. [Year];Volume:[Pages]. DOI:
- [Author list]. [Title]. [Journal]. [Year];Volume:[Pages]. DOI:
Conference Presentations
- [Author list]. [Title]. [Conference name]. [Location]. [Year].
- [Author list]. [Title]. [Conference name]. [Location]. [Year].
Book Chapters/Reviews
- [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: ___