Posts

Change management for an eye surgery device in development
Ensuring that changes to the eye surgery device in series production comply with regulatory requirements.
Change coordination and administrative support
The introduction of a standard change process and the creation of technical documentation ensured efficient project progress.

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.

Validation / Qualification
Compliant and efficient

Software in the Medtech industry (IEC 62304)
Always compliant and efficient

Risk Management
Risks always under control

Requirements Engineering
Requirements clearly elaborated

DevOps, CI/CD
Efficient software development