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Master Data
Management

for Medical Devices

Centralize, validate, and syndicate enterprise product
data across regulatory, quality, and supply chain.

Visu-smartMaster-app-mock-updated

Core Challenge: Fragmented Device Data

How may Products are in R&D and how many in commercial in what countries ? Seem simple
question but invokes different answers from different functions.

When product data is scattered across ERPs, PLM platforms, localized spreadsheets, and regulatory
filings, manufacturers face compliance risks and tedious manual work on data retieving/reconciliation:

data-fragmentation

Data Fragmentation & Silos

Regulatory Affairs, Packaging, Quality, and Supply Chain operate on disparate versions of product truth.

compliance-rejection-risks

Compliance & Rejection Risks

Manual data entry and inconsistent attributes lead to costly rejections from health authority databases (FDA GUDID, EU  EUDAMED, NMPA).

manual-tasks

Manual tasks & Operational efficiency leakage

Managing regulatory, quality audits, UDI and product changes country-by-country drives up manual efforts.

quality-recall

Quality & Recall Vulnerabilities

Lack of granular traceability across data relationships/hierarchy and registration dossiers increases audit risk.

How Visu smartMaster will help

smartMaster is the Master Data Management (MDM) module built directly into the DDi Visu
compliance and regulatory platform. Designed specifically for manufacturers, smartMaster acts
as your Single Source of Truth (SSOT). It pools, harmonizes, and governs medical device master data
across product lifecycles connecting raw product specifications, packaging hierarchies, regulatory registrations,
and global UDI submissions in to a single cohesive platform.

Key Capabilities of Visu smartMaster

data-harmonization-normal

1. Master Data Harmonization

Break down functional silos by consolidating product, regulatory, packaging, and commercial attributes into unified master records:

  • Product & Device Master: Device classifications, GMDN/EMDN codes, risk classes, and technical specifications.
  • Packaging & Labeling Data: Multi-level packaging hierarchies (Unit, Inner, Master, Pallet) and global GTIN/UDI mapping.
  • Regulatory & License Tracking: Cross-link core device data with market approvals, clearance certificates (510(k), PMA, CE Mark), and dossier records.
automated-validation-normal

2. Automated Validation & Proprietary smartRules Engine

Ensure total submission compliance prior to publishing:

  • Pre-Submission Quality Checks: Detect missing mandatory fields, formatting errors, and country-specific rule conflicts before publishing.
  • Real-time Change Detection: The integrated smartRules engine monitors daily data updates across departments and automatically flags impacted global markets UDI  records, or registration submissions.
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3. Enterprise Ecosystem Integration

Seamlessly connect with existing infrastructure:

  • System Agnostic: Pre-built connectors and robust REST APIs seamlessly synchronize data with existing ERP (SAP, Oracle), PLM (Agile, PTC), QMS, RIM, and labeling software.
  • GDSN & Commercial Syndication: Automatically publish validated master data to commercial partner data pools and GDSN networks without manual re-keying.
Regulatory Traceability & Governance

4. Regulatory Traceability & Governance

Audit-ready governance built for Life Sciences:

  • 21 CFR Part 11 & Annex 11 Compliant: Complete system audit trail capturing every data change, approval workflow, user action, and verification step.
  • Role-Based Access Control (RBAC): Assign domain-specific ownership (e.g., Regulatory owns submission fields, Packaging owns GTINs/dimensions, Quality owns risk attributes).

Why Choose Visu smartMaster?

Traditional MDM / Spreadsheets Visu smartMaster
Handled via static Excel files and localized databases Dynamic, cloud-based single source of truth tailored specifically for Life Sciences
Generic data schemas requiring extensive custom coding Out-of-the-box support for medical device data models & global UDI standards
Manual validation against evolving health authority rules Automated validation powered by built-in regulatory intelligence and smartRules
Fragmented visibility between PLM, ERP, and RIM Bi-directional integration connecting regulatory filings directly to supply chain and product data

Transform Your Medical Device Master Data Management

Eliminate data silos, automate health authority compliance, and accelerate time-to-market with Visu smartMaster. See how our Life Sciences MDM platform works in action.

Schedule a Demo

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