Matrix eIFU and IFUcare, compared on published facts
Both are cloud based electronic instructions for use solutions built for Regulation (EU) 2021/2226 and international eIFU requirements. Every statement about IFUcare on this page comes from QARAD's own published documentation and links to it. Where the two products do the same thing, we say so.
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Compiled from information published by each vendor and checked on 19 August 2026. Pricing, support responsiveness, implementation duration, ease of use and system performance are not compared, because they cannot be established as fact about another vendor's product from the outside. Bracketed numbers refer to the sources listed below.
Six things worth checking yourself
eIFU solutions look similar on a feature list and differ in the detail. Each one ends with the question that settles it.
Certification against framework
A vendor may hold certifications such as ISO 9001, ISO 13485 or ISO/IEC 27001. These standards address different aspects of how an organisation operates, so the important questions are what is certified, who holds the certificate, and what its scope covers. Certified hosting is different: the certificate may belong to the hosting provider or data centre rather than the vendor.
Who publishes the content
Most eIFU vendors let your team upload and publish directly, and also offer expert help. What differs is what is included, what is chargeable, and whether anything is mandatory.
What the analytics actually show
Access reporting ranges from download counts to search patterns, geographic breakdown and availability monitoring. Ask to see the real dashboard, not a slide of it.
Languages and market coverage
Language counts are quoted differently by every vendor. What matters is the markets you sell into and whether translation workflow and version control cover all of them.
Paper on request and notifications
All global eIFU regulations, for example Regulation (EU) 2021/2226, require that device users can request a paper copy of the IFU free of charge within a reasonable time, which is 7 calendar days in the EU. Confirm that this process is handled by the service provider, not by your team. And make sure a notification for safety updates of the IFU is available and under your control.
Getting your content back out
Your IFUs, translations and version history are regulatory records. Migration in is easy everywhere. Migration out, with version history intact, is the question that protects you later.
Compliant eIFU creation, hosting and distribution in one platform
The challenge
Publishing and maintaining compliant electronic instructions for use at global scale
- Fragmented IFU content and versionsInstructions for use, translations and revisions get scattered across documents and drives, making it hard to prove that every market always sees the current, approved version.
- Complex EU MDR eIFU rulesRegulation 2021/2226 sets strict conditions for when and how an eIFU may replace paper, including retaining previous versions and providing paper on request within set timeframes.
- A heavy multilingual burdenEach market can require the IFU in its own language, and keeping dozens of translations synchronised with the master is slow and error prone.
- Always on accessibilityeIFUs must be reachable to end users continuously, including low bandwidth and offline situations, with uptime you can evidence to an auditor.
Our solution
Compliant eIFU creation, hosting and distribution in one platform
- A single source of truth for IFUsAuthor, version and approve every IFU and translation in one controlled system, with a complete history behind every change.
- Built for EU MDR and FDA eIFU rulesMatrix eIFU is designed around Regulation 2021/2226 and FDA expectations, including previous-version retention and paper on request workflows.
- Effortless multilingual publishingManage every language variant against a single master and publish them together, so no market is ever left on an outdated version.
- Reliable global hostingContent is served from resilient, ISO 27001 hosting with the uptime and access you can evidence to an auditor.
Full source list
Bracketed numbers above refer to this list. All sources are published by the named vendor and reachable without a login, except the internal confirmation at [6]. Checked 19 August 2026.
- 1Matrix eIFU product page, Matrix One.https://matrixone.health/products/matrix-eifu
- 2Matrix Req product page, Matrix One.https://matrixone.health/products/matrix-req
- 3Matrix Quality product page, Matrix One.https://matrixone.health/products/matrix-quality
- 4IFUcare, QARAD BV.https://ifucare.io
- 5QbD Group, quality assurance services.https://qbdgroup.com/en/services/quality-assurance
- 6Matrix One internal confirmation. Confirmed by the Matrix One product team, August 2026, and not yet documented publicly: Matrix eIFU end user access analytics, and a global customer base. Action: add both to the Matrix eIFU product page so these claims are publicly verifiable.
Methodology and corrections
Scope. This page compares Matrix eIFU and IFUcare on features that can be verified against each vendor's published documentation. It is not a review, a benchmark or a ranking. It does not assess pricing, support responsiveness, implementation duration, ease of use or system performance.
Method. Statements about IFUcare are drawn from QARAD's own website and product documentation. Where we could not verify something we say so and make no claim. Review and aggregator sites were not used as the basis for any factual statement on this page.
Where both products match. On the eIFU platform itself, Regulation (EU) 2021/2226, control of publishing and updates, end user analytics, a global customer base and a customer base in IVD and medical devices, both vendors provide the same thing. The table says so rather than leaving a blank that reads as a gap. The one genuine difference is the other competencies row: ours is software, theirs is consulting.
Trademarks. IFUcare and QARAD are trademarks of QARAD BV. QbD Group is a trademark of its respective owner. Matrix One is not affiliated with, endorsed by or sponsored by QARAD BV.
Corrections. If you believe anything on this page is inaccurate or out of date, including if you work at QARAD, email corrections@matrixone.health. We will review it, correct what is wrong, and record the change and its date here.
Version. First published July 2026. Last reviewed 19 August 2026. This revision: comparison rewritten and sources added following correspondence from QARAD BV. Corrections log: 19 August 2026, comparison rewritten.
Move your eIFU content in 4 steps
We handle the heavy lifting. Timelines depend on how many IFUs, languages and markets you carry, so we scope that with you.
We review your current IFUs, languages and markets, and tell you plainly what will transfer cleanly and what will not.
IFUs and translations imported, versioned and linked, with version history preserved.
Access rules, QR links and compliance workflows configured, with documentation for your validation file.
Full onboarding with a dedicated Customer Success Manager.
Thank you
A member of our team will be in contact within 48 hours.
eIFU, requirements and quality from one software vendor.
Matrix eIFU delivers compliant electronic instructions for use through your own branded website. Matrix Req covers requirements management and Matrix Quality covers quality process management. Book a demo with one of our specialists today.