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electronic
Instructions For Use (eIFU)

Full-Service Solution Provider

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Managing electronic IFUs reduces print costs, manual efforts, and compliance issues. In addition, it’s mandatory for some regions countries. See how DDi can make this transition smoother, cost effective and ensuring compliance.

Why should you consider us:

  • Certified in ISO 13485
  • Single solution provider for both Software and Print service management
  • Audited by multiple Notified Bodies till date
  • Regulatory, Labeling and IT subject experts to guide the transition process
  • Data in ISO 27001 certified data centers (USA/Germany) and GDPR compliant
  • Trusted by many Manufacturers for their eIFU for several years
DDi-eIFU-on-Macbook

SOFTWARE

Website / Portal (examples of What your end users see)

You can try 2 Sample Sites:  Sample 1       Sample 2

Admin Access (from this you manage Data & Documents)

  • MDR (EU 2021/2226), FDA and other regulations Compliant
  • Role & Permission Driven
  • Multi-language, Multi-versions linked by Products and Document versions
  • Enterprise version option with workflows, connect to your PLM & EDMS, custom branding and other premium features
  • 21 CFR Part 11, GAMP compliant and validated
  • Security measures and Privacy Policy are in compliance with GDPR

PRINT SERVICES

  • Full time inhouse Call Center that follows ISO 20000 policies
  • Handle “print” requests and ship hard copies (or optionally, coordinate with manufacturer fulfillment teams if you want to keep this inhouse)
  • Maintain TAT for 7 days (as per EU Regulation)
  • Provide audits trail reports for action by your users to help maintain traceability, and compliance with regulatory requirements.

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