DORCHIES Arnaud

DORCHIES Arnaud (COVARTIM)

Arnaud has a broad 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.

Area of expertises

Set up of QMS as per ISO 13485:2016 and 21CFR820.

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
  • ISO 9001

Technical documentation file.

Answering to health authorities’audits.

Marketing materials review.