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Introducing nemedio QMS.
Quality Management Software that fits your engineering process
key features
Document Control →
Design Control & Traceability →
Risk Management→
Change Control→
Project Management→
intuitive and modern documentation
Document Control
21CFR 11 Compliant
Management of Documents, Records & Procedures
Clear Approval Workflows (customization available)
Practical Peer Review
Compliant Exports
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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