DDi ViSU

End-to-End Regulatory Information Management (RIM) platform for the medical device industry.

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Overview

ViSU by DDi Technology is a cloud-based, end-to-end RIM platform designed specifically for the medical device industry. It enables global users to access and manage Regulatory Data, Dossiers/Tech Files, HA/NB correspondence, Obligations tracking, UDI, eIFU, and Change Control.

✨ Key Features

  • Product Master Data Management
  • Registration and Tracking
  • Dossier/Tech File Management
  • Submission Planning and Lifecycle
  • UDI and eIFU Management
  • Change Control

🎯 Key Differentiators

  • End-to-end platform specifically for medical devices
  • Comprehensive feature set including UDI, eIFU, and Change Control
  • Cloud-based and designed for global access

Unique Value: Offers a complete, cloud-based RIM platform tailored to the specific needs of the medical device industry, from dossier management to UDI compliance.

🎯 Use Cases (5)

Managing technical documentation for EU MDR/IVDR Tracking global product registrations Planning and building submissions Managing UDI data and compliance Controlling changes to regulated products

✅ Best For

  • Comprehensive RIM for medical device manufacturers
  • End-to-end dossier management
  • Centralized regulatory data and document control

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Pharmaceutical and biotech companies
  • Organizations that do not need a dedicated MedTech RIM system

🏆 Alternatives

Rimsys Veeva Vault RIM for MedTech IQVIA RIM Smart

Provides a more focused and feature-rich solution for medical device companies compared to general life sciences platforms.

💻 Platforms

Web API

🔌 Integrations

API

🛟 Support Options

  • ✓ Email Support
  • ✓ Phone Support
  • ✓ Dedicated Support (Varies tier)

🔒 Compliance & Security

✓ GDPR ✓ ISO 27001 ✓ SSO ✓ 21 CFR Part 11 ✓ ISO 13485

💰 Pricing

Contact for pricing
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