Medical Device & IVD eQMS Solution
Full Design Controls, ISO 13485:2016 & EU MDR/IVDR Compliance
Purpose-built for Class I, II, and III medical device manufacturers and In Vitro Diagnostic (IVD) innovators. Streamline Design History Files (DHF), Device Master Records (DMR), and Post-Market Surveillance (PMS).
What Gets Activated Instantly at Onboarding
Pre-Seeded Industry Roles
- Person Responsible for Regulatory Compliance (PRRC)
- Design Assurance Lead
- Quality Manager
- CAPA Coordinator
Document Types & Numbering
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
- Clinical Evaluation Reports
Risk Assessment Matrix
ISO 14971 Hazard Analysis (Hazard → Hazardous Situation → Harm)
Pre-Built Workflow Lifecycles
Design Change Verification, Post-Market Complaint Handling, Vigilance Reporting Triggers
Operational Advantages for Your Sector
Accelerate FDA 510(k) / De Novo and CE Mark technical documentation readiness.
Automated linkage between customer complaints, ISO 14971 risk files, and CAPA.
Audit-ready Design Control matrix with full requirement-to-verification traceability.
Organization-wide tier access lets R&D, Clinical, and Manufacturing collaborate seamlessly.
Launch Your Turnkey Medical Device & IVD eQMS Solution
See the exact pre-configured GxP workflows, templates, and qualification evidence designed for your sector.