
With efficient sprints to country approvals
Country approvals efficiently achieved with standardized sprint processes and the bundling of changes.

Change management for an eye surgery device in development
Ensuring that changes to the eye surgery device in series production comply with regulatory requirements.
Änderungskoordination und administrative Unterstützung
Die Einführung eines Standard-Änderungsprozesses und die Erstellung der technischen Dokumentation gewährleisteten einen effizienten Projektfortschritt.

Revolutionary insulin pump system
With medical technology know-how, we were able to support PharmaSens with the successful FDA submission of their insulin pump system.