Regulated Process Services

We can support you with:

  • Safety and (Cyber) Security Risk Management

  • Usability Engineering and Management

  • Interdisciplinary Project Management

  • Remediation Project Management

  • Product Lifecycle Management

  • Software- and Hardware Lifecycle Management

  • Requirements Engineering and Management

  • Configuration and Change Management

  • CAPA Management

  • Manufacturing Process (Production) Management

  • Platform Engineering and Management

  • Waste Management

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products