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Stages for Medical

Companies that develop medical devices and systems face the tough challenge of mastering complex processes, that is; increasing productivity while ensuring compliance with all the applicable rules.

We can help you resolve this complexity by:

  • Interpreting, summarizing, and modeling pertinent standards in clear, actionable system development steps. (Unified Reference)
  • Visualizing your processes with views that automatically adapt to changes.
  • Reviewing legacy processes to ensure compliance with standards.
  • Tailoring processes.
  • Conducting automated GAP analyses to follow up adaptations to conformance changes.
  • Managing development projects in accordance with compliant processes.
Stages Unified Reference EU (UR.EU)
Stages Unified Reference EU (UR.EU)
Stages Unified Reference FDA (UR.FDA)
Stages Unified Reference FDA (UR.FDA)


All Standards Overview 

Rest assured that with Stages, you will work in conformance with standards and with greater agility. You can even substantiate this compliance for an auditor at the touch button with a Stages report. And your development team receives clear, step by step instructions on when to perform a project task and how to document this work. This ensures your documents always remain up to date.

We go even further, analyzing the applicable standards to derive an agile model process that can serve as a best-practice template for your working methods. All this brings the benefits of both standards conformance and greater flexibility to your workflows.

Your benefits

  • Transparent standards and an easily understood process view
  • Compliant processes, with all digressions identified in time
  • Visualization
  • Update services

Screenshots

Stages for Medical - Plan Risk Management (FDA)
Risk Management (FDA)
Quality Management (FDA)
Quality Management (FDA)
Stages for Medical - Design Validation (FDA)
Design Validation (FDA)
Stages Automotive Metrics
Metrics
Stages Automotive Compliance Workbench
Compliance Workbench
Stages Automotive Document Overview
Document Overview

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