Regulated & Industry Verticals · Documentation
Device R&D
QMSR / ISO 13485 design controls, risk management with computed residual-risk acceptability, design history and device master records, regulatory pathway, UDI, EU MDR / EUDAMED, and post-market surveillance.
Overview
Design controls, risk files, DHF/DHR, and UDI. QMSR / ISO 13485 design controls, risk management with computed residual-risk acceptability, design history and device master records, regulatory pathway, UDI, EU MDR / EUDAMED, and post-market surveillance.
Who it's for. Medical-device makers who need engines, not CRUD shells.
Capability reference
10 capabilities ship in this module. Each is a live surface in the app.
- Overview
- Design Controls
- Risk Management
- Regulatory Pathway
- Post-Market Surveillance
- UDI
- EU MDR / EUDAMED
- DMR
- DHR
- DHF
How it connects
Device R&D shares the platform's single database — the same customers, items, orders, and audit trail as the rest. Related modules: Food & Beverage · Cosmetics · Pharma & Biologics · Life Sciences · Regulatory Affairs · Clinical Trials · Pharmacovigilance · R&D · Nonprofit.