Introducing nemedio cTools.

Quality Management System software and compliance tools that fit your engineering process
intuitive and modern documentation

Document & Change Control

  • 21CFR 11 Compliant
  • Management of Documents, Records & Procedures
  • Clear Approval Workflows
  • Practical Peer Review
  • Guided Change Orders
efficient & convenient management

Design Control & Traceability

  • Single source of truth for managing Design Inputs
  • Seamless data management from User needs to Design Transfer to generate DHFs
  • Individual field configuration for data types
  • Intuitive and flexible trace matrix
  • Peer review capability
Compliant & Engineering centered

Risk Management

  • ISO 14971 Compliant
  • Mitigation tracking in parallel to device engineering
  • Current and new risk tracking
automatically managed training records

Learning Management

  • Document change management
  • Change Orders
  • Integration task/project management
  • Impact assessment assistance to identify records impacted by changes
Compliant & Engineering centered

Project Management

  • Task Creation and Assignment
  • Tasks Integrated into Change Orders
  • CAPA Based Tracking

Want to learn more?

Request Demo