eIFU Infrastructure Supporting EU MDR 2017/745 & IVDR 2017/746 Requirements

eIFU software.Controlled document access.

Electronic instructions for use software for medical device manufacturers

Connect products to electronic instructions for use. Manage revisions, document languages and paper IFU requests through a portal under your brand. Bring quality, regulatory and operations teams together around the same product scope.

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Languages

Use the user-facing application in 68 languages. Give international users a localized experience across your target markets.

Countries and territories

Define your target markets with 290+ country and region options. Manage product and document access for your international operations.

GUIDED DEMONSTRATION

A demo workflow for your products.

Walk through one representative product with your quality, regulatory and operations teams. We will agree the demonstration scope around your needs.

01

Find the product

Review product reference or GTIN search, a shared portal QR and a product-specific link.

Document portal

02

Select the access scope

Assess audience, country and document language together. Check interface language separately from document language.

Multilingual documents

03

Trace the revision decision

Use the document workspace to distinguish draft, independent review, approval and publication. Review earlier decision records.

Approval and publication workflow

04

Track a paper request

Review the product, document language, owner and target date in the request queue. Distinguish dispatch from request fulfilment.

Paper IFU requests

Start with your product range, document languages and target markets, wherever your team is based. The demonstration does not replace assessment of electronic delivery eligibility or the manufacturer’s quality and regulatory decisions.

Share your demo scope in the form

CONNECTED DOCUMENT MANAGEMENT

Control for your team.
Access for your users.

Support your electronic IFU workflow from document preparation to product access.

Electronic instructions for use

Help healthcare professionals and patients find the relevant document using a product reference, GTIN or permanent QR link. Define the audience for each document.

Controlled document revisions

Prepare, review and approve new revisions. Keep previous versions and decision records connected to the same product.

Multilingual document access

Define document languages and market coverage by product. Identify missing required language versions before publication.

Paper copy requests

Track requests, responsibilities, target dates, dispatch and delivery alongside your document workflow.

Document usage reports

Review views, downloads and revision follows by document, country and language.

A portal under your brand

Present product documents through a portal with your company logo, brand colour and domain. Give your team access with appropriate permissions.

GETTING STARTED

From your first document
to your first QR code.

  1. 01

    Configure your portal

    We prepare your branding and technical setup. Invite your team with the appropriate permissions.

  2. 02

    Map your documents

    Define products, document types, audiences, markets and languages. Complete your review and approval process.

  3. 03

    Share and monitor

    Share permanent product links and monitor document usage, requests and revision follows.

REGULATORY RESPONSIBILITY

Tools to support your quality team.

The platform provides tools for controlled publishing, revision records, language coverage and request management. It does not certify regulatory compliance. Your quality and regulatory teams must assess product eligibility, intended users, markets, languages and delivery obligations. EU and Türkiye requirements must be assessed separately.

BEFORE YOU BEGIN

Your questions,
answered.

Let’s assess your products and document workflow together.

Talk to us
What is an electronic IFU?

An electronic instruction for use is product information made available electronically. An eIFU platform connects that information to products and supports access, version control and user requests. Whether electronic delivery is appropriate depends on the device, its users and the applicable market requirements.

Can we use a single QR code or product-specific QR codes?

Both approaches are supported. A shared QR code opens the portal search. A product-specific QR code opens the relevant product documents. Visitors can select the audience, country and document language.

Does the platform support documents in different languages?

You define the language and market coverage for each product and document. Required language versions can be checked before a new revision is published.

Does using this software guarantee compliance?

No. The platform provides tools to support controlled publishing and document management. Your quality and regulatory teams remain responsible for product eligibility, risk, languages and delivery requirements in each target market.

Can we arrange a demonstration in English?

Use the request form or WhatsApp to discuss an English demonstration around your products, markets and document workflow.

How do setup and pricing work?

We first discuss your products, documents, team and target markets. Technical setup, training and a company-specific proposal follow from that scope. Sales and online payment are not yet open.

LET’S DISCUSS YOUR REQUIREMENTS

Plan a demonstration around your products.

We will walk through document access, revision management and multilingual publishing around your product range and markets.

Chat on WhatsApp ↗

DEMO REQUEST

Tell us what you need.

This form prepares a WhatsApp message. Your request is sent only when you send it in WhatsApp. Do not include patient information or confidential documents. Privacy information (Turkish)