Skip to main content
Matrix One>Alternatives>Kallik Alternative
Kallik Alternative

The right-sized alternative to Kallik for medical device teams

Kallik is an enterprise labeling and artwork management platform built for large organisations. Matrix eIFU is a focused, right-sized eIFU platform that deploys faster and connects to your quality suite.

Book a demo
Matrix eIFU vs Kallik: at a glance
Matrix eIFU
Kallik
Focused eIFU platform
✓ Yes
✗ Labeling & artwork suite
Right-sized for SME / mid-market
✓ Yes
✗ Enterprise
Part of an integrated MedTech suite
✓ Yes
✗ No
Fast time to value
Weeks
✗ Enterprise rollout
Self-serve SaaS deployment
✓ Yes
✗ Implementation-led
Cost profile for device teams
Right-sized
✗ Enterprise pricing

This comparison is based on publicly available information and internal analysis as of July 2026. Features and capabilities may change over time. For the most accurate and up-to-date information, you can refer to the official website of Kallik

Common frustrations with Kallik

Teams weighing Kallik against a focused eIFU platform tend to raise the same points.

Enterprise labeling and artwork firstKallik is built around enterprise label and artwork management, so eIFU is one part of a much larger platform rather than the core focus.
Heavy for mid-market device teamsThe enterprise scope, setup and cost can be more than a Class II or III device team needs.
Longer rolloutsEnterprise labeling deployments tend to take longer than standing up a focused eIFU platform.
No integrated quality suiteeIFU content sits apart from your QMS and design records rather than in one connected platform.
Cost profileEnterprise pricing can be hard to justify for teams that primarily need compliant eIFU distribution.
More than you needIf the goal is compliant eIFU hosting and distribution, a full artwork management suite adds scope you may never use.

eIFU management made simple with Matrix eIFU

The challenge
Our solution

Publishing and maintaining compliant electronic instructions for use at global scale

Compliant eIFU creation, hosting and distribution in one platform

  • Fragmented IFU content and versions

  • Instructions 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.

  • A single source of truth for IFUs

  • Author, version and approve every IFU and translation in one controlled system, with a complete history behind every change.

  • Complex EU MDR eIFU rules

  • Regulation 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.

  • Built for EU MDR and FDA eIFU rules

  • Matrix eIFU is designed around Regulation 2021/2226 and FDA expectations, including previous-version retention and paper on request workflows.

  • A heavy multilingual burden

  • Each market can require the IFU in its own language, and keeping dozens of translations synchronised with the master is slow and error prone.

  • Effortless multilingual publishing

  • Manage every language variant against a single master and publish them together, so no market is ever left on an outdated version.

  • Always-on accessibility

  • eIFUs must be reachable to end users continuously, including low bandwidth and offline situations, with uptime you can evidence to an auditor.

  • Reliable global hosting

  • Content is served from resilient, ISO 27001 hosting with the uptime and access you can evidence to an auditor.

  • Traceability back to the device

  • Regulators expect a clear link from the physical device and its UDI to the exact IFU version that is in use.

  • UDI and QR linking

  • Generate QR codes that take each user straight to the correct, current IFU for their exact device and language.

  • Audit and security pressure

  • Content integrity, access control and full version history all have to hold up under inspection.

  • Part of the Matrix One suite

  • Your eIFU content sits on the same platform as your quality and design records, so labelling stays aligned with the rest of your technical file.

    The challenge

    Publishing and maintaining compliant electronic instructions for use at global scale

  • Fragmented IFU content and versions

  • Instructions 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 rules

  • Regulation 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 burden

  • Each 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 accessibility

  • eIFUs must be reachable to end users continuously, including low bandwidth and offline situations, with uptime you can evidence to an auditor.

  • Traceability back to the device

  • Regulators expect a clear link from the physical device and its UDI to the exact IFU version that is in use.

  • Audit and security pressure

  • Content integrity, access control and full version history all have to hold up under inspection.

    Our solution

    Compliant eIFU creation, hosting and distribution in one platform

  • A single source of truth for IFUs

  • Author, 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 rules

  • Matrix eIFU is designed around Regulation 2021/2226 and FDA expectations, including previous-version retention and paper on request workflows.

  • Effortless multilingual publishing

  • Manage every language variant against a single master and publish them together, so no market is ever left on an outdated version.

  • Reliable global hosting

  • Content is served from resilient, ISO 27001 hosting with the uptime and access you can evidence to an auditor.

  • UDI and QR linking

  • Generate QR codes that take each user straight to the correct, current IFU for their exact device and language.

  • Part of the Matrix One suite

  • Your eIFU content sits on the same platform as your quality and design records, so labelling stays aligned with the rest of your technical file.

    24/7
    Always-on access
    Your eIFUs stay available to end users around the clock, on any device.
    100%
    Version controlled
    Every IFU and translation is versioned and auditable, with previous versions retained.
    40+
    Global reach
    Publish and maintain instructions for use across dozens of languages and markets.

    See exactly how the two options stack up on the criteria that matter most to medical device labelling teams.

    Matrix eIFU
    Kallik

    Comparison based on publicly available product information from both vendors as of July 2026. Features and capabilities may change over time.

    — PURPOSE & FIT —
    Purpose-built for medical device eIFU
    Part of an integrated MedTech suite (QMS & ALM)
    Right-sized for SME and mid-market device teams
    — COMPLIANCE —
    EU MDR eIFU compliance (Reg. 2021/2226)
    FDA eIFU support
    Previous-version retention
    Paper on request workflow
    Multilingual publishing (all EU languages)
    ISO/IEC 27001 certified hosting
    Full version control & audit trail
    21 CFR Part 11 electronic signatures
    — USABILITY & DEPLOYMENT —
    Self-serve SaaS platform
    Time to value
    Weeks
    Enterprise rollout
    No mandatory consultancy retainer
    Partial
    UDI / QR code generation & linking
    — DISTRIBUTION & ACCESS —
    Resilient global hosting with uptime SLA
    End-user access analytics
    Partial
    Low-bandwidth / offline access
    — SUPPORT & SERVICE —
    European in-timezone support
    Dedicated customer success manager
    Matrix eIFU
    — PURPOSE & FIT —
    Purpose-built for medical device eIFU
    Part of an integrated MedTech suite (QMS & ALM)
    Right-sized for SME and mid-market device teams
    — COMPLIANCE —
    EU MDR eIFU compliance (Reg. 2021/2226)
    FDA eIFU support
    Previous-version retention
    Paper on request workflow
    Multilingual publishing (all EU languages)
    ISO/IEC 27001 certified hosting
    Full version control & audit trail
    21 CFR Part 11 electronic signatures
    — USABILITY & DEPLOYMENT —
    Self-serve SaaS platform
    Time to value
    Weeks
    No mandatory consultancy retainer
    UDI / QR code generation & linking
    — DISTRIBUTION & ACCESS —
    Resilient global hosting with uptime SLA
    End-user access analytics
    Low-bandwidth / offline access
    — SUPPORT & SERVICE —
    European in-timezone support
    Dedicated customer success manager
    Kallik
    — PURPOSE & FIT —
    Purpose-built for medical device eIFU
    Part of an integrated MedTech suite (QMS & ALM)
    Right-sized for SME and mid-market device teams
    — COMPLIANCE —
    EU MDR eIFU compliance (Reg. 2021/2226)
    FDA eIFU support
    Previous-version retention
    Paper on request workflow
    Multilingual publishing (all EU languages)
    ISO/IEC 27001 certified hosting
    Full version control & audit trail
    21 CFR Part 11 electronic signatures
    — USABILITY & DEPLOYMENT —
    Self-serve SaaS platform
    Time to value
    Enterprise rollout
    No mandatory consultancy retainer
    Partial
    UDI / QR code generation & linking
    — DISTRIBUTION & ACCESS —
    Resilient global hosting with uptime SLA
    End-user access analytics
    Partial
    Low-bandwidth / offline access
    — SUPPORT & SERVICE —
    European in-timezone support
    Dedicated customer success manager

    Switching is easy

    Move to Matrix eIFU from Kallik in 4 simple steps

    We handle the heavy lifting. Most teams are publishing compliant eIFUs within weeks.
    Free migration assessment (30 min)

    We review your current IFUs, languages and markets and map them to Matrix eIFU.

    Content import & mapping

    Your IFUs and translations are imported, versioned, and linked to the right devices.

    Configure, validate & sign off

    Access rules, QR links, and compliance workflows configured with validation documentation.

    Go live and stay compliant

    Full onboarding with a dedicated Customer Success Manager from day one.

    Full onboarding with a dedicated Customer Success Manager from day one.
    CV
    Carl Van Lierde
    VP Product Development, Vipun Medical
    Book your migration assessment
    Free 30-min session
    No credit card
    No spam, ever

    Thank you

    A member of our team will be in contact within 48 hours.

    Stop wrestling with PDFs and paper IFUs.

    Start distributing compliant eIFUs with confidence.

    Join the medical device teams that trust Matrix eIFU to publish and maintain their instructions for use. Book a demo with one of our specialists today.