Profile Details

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Hire QUYNH N.

Vietnam

USD 150 /hr

Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDR/ Performance evaluation IVDR

Profile Summary

EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENCES: THIRD EXPERIENCE: Clinical Evaluation process: clinical evaluation via the literature route on Medical Devices according to the MEDDEV 2.7/1 rev. 4 (2016) and compliant with the General Requirements of European Medical Device Regulation (MDR) - Medical Device: EXOSKELETON - Key Relevant Skills: Literature searches protocol, Clinical trial searches, Equivalence Assessment, extension population strategy. Clinical Procedure: - establish and update clinical evaluation process - input for PMCF strategy SECOND EXPERIENCES Engaging in clinical evaluation via the literature route on Medical Devices according to the MEDDEV 2.7/1 rev. 4 (2016) and compliant with the Essential Requirements of EC 93/42 Directive and its modification by EC 2007/47 Directive and the European Medical Device Regulation (2017) - Clinical Evaluation Report (CER) on Peripheral Vascular, Cardiology, Orthopedics, Dermatology, Dental and wound care - Key Relevant Skills: Literature searches, Clinical trial searches, Pre-clinical and clinical evaluation; Equivalence Assessment, Post-Market Surveillance, Quality Check for CER - Devices: Vascular Access Devices (Catheter, Implantable Port, microcatheter, etc), Infusion Sets, Spinal System, Dermal Fillers Bandages & Wound dressing, Hemostatic Surgical Dressing, Devices for Orthopedic Surgery (bone fixation, bone cut, cage, etc), Dental (Palatal Expander) - Building internal CER library of different devices within diverse therapeutics area. FIRST EXPERIENCE: Project : The role of Rad51 paralogs in the maintenance of genome integrity Achievements: Project development & management - Organising and Planing the experiments - Conducting and testing the hypothesis for project advancement - Analysing the data and Confirm by statistical tests - Reporting the results and Defending the project within the research group Technical expertise: PCR; Protein purification (AKTA system), Gene expression & modification, Gene knockdown & KO, siRNA, Western Blot, EMSA, ELISA, Transfection, FACS, Cloning, immunofluorescences, etc.

Subject Matter Expertise

• ★ Clinical Evaluation Reports (CER)
• ☆ STEM
• ☆ Biology/Life Sciences
• ☆ Molecular Biology
• ☆ Medical Devices
• ☆ Medical Device Marketing
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ Hypothesis
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Trial Protocol Writing
• ☆ SEO Medical Writing
• ☆ Science Communication
• ☆ Risk Management

Services

• Writing
• Research

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Fact Checking, Systematic Literature Review, Secondary Data Collection

Work Experience

MDR consultant

ALTOGEN

January 2020 - January 2020

Medical Writer - Regulatory consultant

NAMSA consulting

February 2018 - October 2019

Research Intern

Cancer Research Center of Marseille

February 2017 - June 2017

Education

Master degree in Science, Technology and Health

Sorbonne university, Paris VI, France

September 2015 - June 2017

Certifications

• Certification details not provided.