Product Swiss Medtech Expo 2021

e-IFU/eManuals Solution - Smart Tools for Compliance

We provide an innovative tool to manage your IFU digitally and in full compliance with MDR regulation. This will result in huge savings and burden reduction for your company.

  • Package scan and retrieve
    Package scan and retrieve
  • Electronic Instruction for Use (IFU) - eIFU
    Electronic Instruction for Use (IFU) - eIFU
  • Implant
    Implant

Key Feature

  • Web App Dedicated back end to manage documentation
  • Revision management
  • Guarantee that only approved templates and content are used with version control
  • QR scan and download
  • Personalized front end
  • Language management
  • Product family grouping
  • Multidocuments management
  • Local language self recognition
  • Blockchain Audit Trail

STAY Compliant solution fully compliant with EU and FDA regulations (MEDDEV 2.14/3 for IVD and Commission Regulation (EU) No. 207/2012 on MD)

  • Key Benefits
  • Save on printing and managing all related paper process
  • Developed by Regulatory Compliance Experts
  • Organize all your instructions for use and make them available to your customers DON’T BREAK THE SEAL - review product documentation without having to break your products seal.
  • Tamper Proof via blockchain Audit trail compliant to 21 CFR Part 11 on Blockchain Quick and easy retrieve via QR code Scan
  • From an off-the-shelf solution to a fully tailor-made platform.

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