Design & Device History File
Structured DHF and DHR management with change-controlled document links, revision history, and automated completeness checks for every production lot.
Industry Solutions: Medical Devices
Build Safer Devices Faster with Medical Device ERP
From design history file to post-market surveillance, our ISO 13485-aligned ERP enforces DHR completeness, MOHAP medical-device registration, UDI assignment per ESMA requirements, CAPA closure, and complaint trending - giving your quality and operations teams a single source of truth across the entire device lifecycle.
Device Quality ConsoleLive
Open CAPAs
7
-3
UDIs Registered
4,820
DHR Completeness
99.6%
ISO 13485:2016 AlignedMOHAP Medical Device Registration ReadyESMA UDI Compliant
35%
Faster CAPA closure
99.6%
DHR completeness rate
The Challenge
The roadblocks VOIITS clears for Medical Devices teams
Each one handled out of the box - no spreadsheets, no workarounds.
Design History File & DHR Maintenance
One system for every DHR record - always current, always audit-exportable.
MOHAP Device Registration & Global Labeling Compliance
Auto-populated device labels and MOHAP-ready data - zero labeling non-conformances.
Supplier Control & Incoming Inspection for Critical Components
Inspection results feed supplier scorecards automatically - ISO 13485 ASL controls met.
Post-Market Surveillance & Complaint Traceability
Every complaint tied to a serial number and CAPA - closed-loop, MOHAP-ready reporting.
Capabilities
Enterprise-Grade Medical Devices Modules
End-to-end quality, production, and post-market tools for Class I, II, and III device makers.
Quality & CAPA Management
ISO 13485-aligned CAPA, nonconformance, and supplier corrective action workflows with effectiveness verification checkpoints and real-time closure metrics.
UDI & Label Management
Automated UDI-DI and UDI-PI assignment per ESMA requirements, barcode generation, and direct MOHAP registration submission - eliminating manual data re-entry between labeling and UAE regulatory systems.
Post-Market Surveillance
Centralized complaint intake, MOHAP adverse-event reporting and trend analysis, and periodic safety update report (PSUR) aggregation with configurable signal-detection thresholds.
Compliance & Security
Device-grade quality, MOHAP-registered and traceable
From DHR to UDI - built for regulated device manufacturing and import.
ISO 13485
Device QMS with controlled documents, CAPA, and design history records.
MOHAP device registration
Product, classification, and dossier data structured for MOHAP submissions.
ESMA conformity
Emirates Conformity Assessment and labeling tied to every lot and serial.
ISO 14971
Risk management evidence linked to design, production, and complaints.
Post-market surveillance
Complaint handling and vigilance reporting with full traceability.
Supplier qualification
Approved-vendor controls and incoming inspection per clause 7.4.
Reconstruct full forward/backward traceability for any device in seconds.
- 35%
- Faster CAPA closure
- 100%
- DHR completeness at audit
- 2×
- Faster UDI submission cycle
FAQ
Medical Devices ERP - your questions, answered
The things growing UAE teams ask us most before getting started.
Yes - VOIITS is built around the ISO 13485 quality management framework, covering document control, non-conformance management, CAPA, supplier qualification, and Device History Records required for MOHAP registration in the UAE. Our implementation team maps each regulatory clause to the corresponding VOIITS workflow during onboarding.
Production orders generate serial or lot numbers at any level - sub-assembly, finished device, or sterile pack - and the system records which supplier lots of critical components were consumed, all inspection outcomes, and the customer or distributor the device shipped to. A one-click genealogy report covers the full chain, essential for targeted field corrections and MOHAP recalls.
VOIITS supports configure-to-order and engineer-to-order workflows alongside make-to-stock production. For custom devices, customer-specific BOMs and routing variants are created from a base configuration, with the customer order reference carried through every production document into the Device History Record.
A single-site medical device implementation typically takes 14 to 20 weeks. VOIITS provides IQ/OQ/PQ protocol templates calibrated for the device industry, and our team has experience supporting validation aligned with MOHAP and ISO 13485 - helping you contain validation costs well below the project total and coordinate submissions with your Regulatory Affairs function.
Non-conforming items flagged at incoming inspection, in-process, or final inspection are automatically quarantined and a Non-Conformance Report is raised. The NCR drives a structured disposition workflow - use-as-is, rework, or reject - and can escalate to a CAPA with assigned owner, due date, effectiveness check, and closure approval, all linked to the affected lot or serial number.
VOIITS records sterilization cycle data (date, method, cycle number) against each production lot and enforces FEFO picking based on sterility expiry dates. Minimum remaining shelf-life rules are configurable per customer or distribution channel, and expired lots are blocked from dispatch automatically.
Ready to Elevate Your UAE Quality System?
Partner with VOIITS to build MOHAP-compliant, traceable, and audit-ready medical device operations from design to post-market in the UAE.