プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Wim V.に依頼

Belgium

Independent Consultant Clinical Research Management | MedTech | EU MDR | ISO 14155 | FDA | Pre- & Post-Market Trials

プロフィール概要

I am an experienced independent consultant specializing in clinical research management for medical devices, with a focus on EU MDR compliance, ISO 14155, and FDA regulations. Over the past 15+ years, I have led and supported multiple pre-market and post-market clinical investigations, including complex Class III and AIMD trials, and provided strategic input from protocol development through to clinical study reports and regulatory submissions.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ European Medical Device Regulation (MDR)
• ☆ Clinical Trials
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Nursing
• ☆ Feasibility Studies

サービス

• Writing
• Research

Writing Clinical Trial Documentation

Research Feasibility Study

職務経験

Clincial Research Consultant

C-VERSA

5月 2022 - 現在

Senior Global Clinical Program Manager Epilepsy

LivaNova

11月 2018 - 5月 2022

Principal Clinical Research Scientist

Biosense Webster (J&J)

5月 2017 - 11月 2018

Program Manager Neuromodulation

Cyberonics / Livanova

5月 2008 - 5月 2017

学歴

MBA

Rushford Business School

5月 2025 - 現在

Bachelor of Nursing

Katholieke Hogeschool Leuven - Belgium

9月 1997 - 6月 2000

認定資格

• FDA Inspections: From Site Preparation to Response

  CITI Program

  5月 2024 - 現在

• ISO-14155

  CITI Program

  5月 2024 - 現在

• ICH-GCP

  CITI Program

  5月 2024 - 現在