CE Marking and Technical File Maintenance
The Phase 2 Quality Team is experienced in writing Technical Files and attaining CE Mark certification for class
I,
IIa, &
IIb medical devices. We understand the demands and time constraints associated with marketing product, and can begin assembling the Technical File while documentation and process developments are being completed, allowing faster coordination of international approval for your device distribution. This value added service allows you to focus your efforts and resources on product and market development.