THIBAUT Kyun (COVARTIM)
Compétences
Design and development of innovatie medical devices.
Industrialisation and production (ISO 5-7 cleanrooms).
Verification and validation.
Clinical evaluation.
Set up and management of a QMS (ISO 13485).
Establishment of regulatory pathway and strategy (EU and US).
Realisation of technical files.
Management of suppliers & subcontractors.
Management of program budget and planning.
Resources allocation management.
Delivery management.
Exploitation management (exit strategy, valorisation).
Diplôme(s) – Qualification – Certification
Master Degree Mechanical Engineering.
Lecturer at the ECAM and ULB on regulatory affairs for Medical Devices and clinical evaluation.
Trainings :
MDR 2017/745.
Prince2 for Managers.
Project Management Professional.
Operating Theatre Access Qualification.
Prince2 Foundation.
Medical Devices Design Control & Validation.
US FDA Quality Systems Regulation…..
Expérience
Mechanical Engineer with a passion for Life Sciences and Medical Devices, he had the opportunity to work in various companies belonging to the most high-tech industries in the world.
His career has brought him to various positions such as R&D Engineer, Systems Engineer, Project Manager, Product Development Manager, Program Manager. He also had great experiences in Team & Account management and Business Development.
In 2016, driven by his passion for MedTech, he let go to his entrepreneurial spirit and launched Covartim, a Belgian engineering company 100 % focused on Medical Devices, IVD and digital health.