DORCHIES Arnaud (COVARTIM)
Compétences
Set up of QMS as per ISO 13485 and 21 CFR820.
Gap analysis and implementation MDSAP.
Support for CE certification.
Certified internal auditor.
Notification to national competent authorities.
Trainings.
Internal & external audits : ISO 13485, ISO 22442-2, ISO 11137, ISO 17025 and ISO 9001.
Technical documentation file.
Marketing materials review.
Diplôme(s) – Qualification – Certification
Master Quality and Health Products.
Industrial Pharmaceutical Sciences.
Expérience
Experience in Quality Assurance and regulatory affairs in Medical and in vitro diagnostic devices.
Arnaud worked on a lot of various projects including many different technologies and organisations.
He has an extensive experience as lead auditor (internal and supplier) and has successfully occupied the role of QA/RA Manager in many occasions.