nemedio Quality Management System

Introducing nemedio cTools.

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

key features

Document & Change Control → Design Control & Traceability → Risk Management→ Training Management → Project Management→

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

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