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eIFU Software & Services

Improve Patient Safety & Meet Global Regulations

Regulatory agencies and notified bodies require medical device manufacturers to digitize and improve delivery of Instruction for Use (IFU).

We are “SINGLE VENDOR” for your eIFU needs

    • MDR, FDA and other regulations Compliant
    • Role & Permission Driven (for manufacturer login)
    • End consumers/customers access website (without login) and search, view, save, and print, your published IFUs.
    • Multi-language, Multi-versions linked by Products
    • Enterprise version option with workflows, connect to your PLM & EDMS, custom branding and other premium features
    • 21 CFR Part 11, GAMP compliant
    • Data Security, GDPR& High Availability (hosted in ISO 27001 certified Data center in Frankfurt, Germany)
    • Call center service 24×7
    • Take “print” requests and ship hard copies (or optionally, coordinate with manufacturer fulfillment teams)
    • Maintain TAT for 7 days (as per Regulation)
    • Provided audits trail reports for action by your users to help maintain traceability, and compliance with regulatory requirements.
    • Additional professional services like SOPs, Risk analysis

How can you get started?


Try demo version of eIFU site


If you need custom package / service

Frequently Asked Questions (FAQs)

  • Does software comply with regulations for all markets in which the e-IFU will be supplied?

    Yes. EU, FDA. EU MDR, eIFU are some of them.

    How often we are updating country regulations?

    Our team of expert regulatory professionals will regularly update the country specific regulatory requirements.

    Are different versions maintained and how about languages?

    You can maintain multiple versions and ViSU has multi-country & multi-language features included.

    Where is Data & Documents hosted?

    Data is stored in our “Private cloud” hosted in ISO 27001 certified Data center in Frankfurt, Germany (optionally we can give NJ, USA as another option)

    Is software validated (21 CFR part 11 / GAMP)?

    Yes. ViSU is validated as per 21 CFR part 11 and GAMP for electronic records and electronic signatures to ensure accuracy, reliability and consistent intended performance

    What data security is followed?

    All sensitive data information are encrypted end-to-end including data at-rest and in-transit using User management and access control/restriction are followed to ensure only the right people have access to data at the right time and also personal information is accessible only to those authorized who we believe reasonably need to come into contact with that information to provide products or services.

    Is this GDPR compliant?

    Yes. Procedural safeguards, security measures and Privacy Policy are in compliance with GDPR to protect and safeguard GDPR principles

  • How is Support and Requests managed

    We maintain 24×7 Service desk and follow ISO 20000 policies. Service Level Agreement (SLA) will be provided to manufacturer upfront and corresponding reports periodically

    How are papers / print requests managed?

    Once user requests for print IFU, within which timelines a printed version of the IFU will be delivered to them in maximum of 7 calendar days. We can use our courier/shipping or bill to manufacturer preferred vendor or forward these requests to manufacturer for their internal fulfillment.

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