Design Controls & Design History File (DHF)
Trace user needs, design inputs, design outputs, design verification, and design validation in an automated traceability matrix.
MedTech & IVD Regulatory Compliance
ISO 13485 & FDA QMSR Quality Management for Medical Devices
Design History Files (DHF), Device Master Records (DMR), Risk Management (ISO 14971), and CAPA governance.
Medical device manufacturers face the FDA's transition to the Quality Management System Regulation (QMSR) aligned with ISO 13485:2016. Novaqis delivers a pre-validated QMS, DMS, and Training platform with built-in DHF, DMR, Device History Record (DHR), and ISO 14971 risk management workflows.
- ISO 13485:2016 Ready
- FDA QMSR Validated
- ISO 14971 Risk Built-In
- 21 CFR Part 11 Compliant
Capabilities
What you get
Device Master Record (DMR) & Device History Record (DHR)
Govern bill of materials, assembly SOPs, and packaging specifications with step-by-step electronic execution and serial number genealogy.
ISO 14971 Risk Management & Post-Market Surveillance
Integrated FMEA risk analysis linked directly to customer complaints, MDR (Medical Device Reporting), and CAPA effectiveness checks.
Compliance & control
Built for regulated operations
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
CapabilityHow Novaqis delivers it
- Design History File (DHF) Matrix
Automated bidirectional traceability between user requirements, design outputs, and validation tests.
- Device History Record (DHR) Tracking
Captures lot and serial number genealogy, component inspections, and release approvals.
- Post-Market Complaint & MDR Reporting
Structured decision trees for FDA eMDR (21 CFR 803) and EU MDR vigilance reporting.
Outcomes
Why teams choose Novaqis
- 100% turnkey compliance with ISO 13485:2016 and FDA QMSR
- Automated Design Traceability Matrix (DTM) generation in one click
- Zero paper DMR/DHR reconciliation delays on assembly lines
- Unlimited engineering, QA, and production users on site licensing
FAQ
Frequently asked questions
- Novaqis provides specialized workflows for Design Controls (DHF), Device Master Records (DMR), electronic batch/device history records (DHR), ISO 14971 risk management, and complaint handling.