Change Control
Supporting you define, design, track, implement and maintain efficient, compliant change control methods for Processes, Systems or Technical Documentation.
Providing evidence for traceability, approval and verification of changes to your:
Medical Devices, Packaging & Labelling
UDI
EUDAMED Registration
Process Controls
Specifications / Technical Documentation
Quality Management System(s)
Software
Key Suppliers / Contractors
Economic Operators
Our services include the reporting of changes to the relevant Regulatory Authority / Notified Body.
