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.
konplan PharmaSens Integration Lösungsfindung Konstruktion Mechanik Umbau Konzeption

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.
Compliance

Validation / Qualification

Compliant and efficient

Software in the Medtech industry (IEC 62304)

Always compliant and efficient
Medical device development

Risk Management

Risks always under control
Startups

Requirements Engineering

Requirements clearly elaborated

DevOps, CI/CD

Efficient software development