nemedio Quality Management System

Introducing nemedio QMS.

Quality Management Software that fits your engineering process

key features

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

transparent & secure change records

Change Control

Document change management
Change Orders
Integration task/project management
Impact assessment assistance to identify records impacted by changes

compliant and flexible workflow

Project Management

Task management and workflow optimization
Kanban views for task visualization and team collaboration
Change control integration
Compatible with both agile or waterfall workflows

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