Skip to content
Boumans Regulatory Consulting
  • Regulatory affairs
  • Our Services
  • PRRC Academy
  • Ronald Boumans

Dorthe Wallin, QA/RA manager at Cortex Technology ApS, Danmark

2022, July 292022, July 24 by Ronald Boumans

Thank you for a very helpfull piece of advise, when you suggested that I should write a rationale for me being appointed as PRRC in my company. Only a few days later, the auditor asked for it during our Tech File Assessment before (hopefully) achieving our MDR CE certificate.

Categories Endorsements
The strategic importance of the Basic UDI-DI
UDI in the case of systems and procedure packs
© 2026 Boumans Regulatory Consulting • Built with GeneratePress