Industries Medical Devices

Medical Devices Localisation & Labeling — IFU/eIFU, UDI, CER & Post‑market

Practical, regulator‑aware language support for device makers: IFU/eIFU, UDI label text, artwork & braille, CER/SSCP, PMS/PSUR (devices), vigilance comms, technical files and SaMD/HMI UI. We keep language clear, consistent and defensible with reviewer‑independence and bilingual redlines.

ISO 17100 ISO 27001 Aligned to ISO 13485 & 14971 Reviewer‑independent Bilingual diffs Secure delivery
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Printed circuit board of a medical device

What we help you globalise — fast, accurate, regulator‑ready

We provide device‑ready language operations: localisation, internationalisation (i18n), L10n, content adaptation and linguistic validation across these artefacts.

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IFU/eIFU & labeling
Artwork, symbols & braille with proof cycles
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UDI datasets
DI/PI (GS1/HIBCC), GTIN, date formats, phrasing
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CER / SSCP
Reviewer‑friendly language, ready for NB review
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PMS/PSUR (devices)
Vigilance comms with traceable changes
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Tech files · DMR/DHF/DHR
Clear, controlled, versioned content
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SaMD/HMI UI strings
UI prompts, alarms, truncation/nowrap controls
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How we work — simple, traceable, on time

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Scope
Files, markets, terms, evidence needs
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Language work
Localisation → independent review → LQA
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Evidence & delivery
Bilingual diffs, signed PDFs, logs
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SaMD / HMI Strings — multi-language preview & truncation risk

Preview common device UI messages in multiple languages and spot truncation risk at typical device widths. Toggle language, width and nowrap rules; Arabic renders RTL. Results are an estimate (font metrics vary by device).

language EN language DE language FR language ES language AR language JA
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IFU/eIFU & labeling

  • Region‑correct phrases and symbol sets (MDR/IVDR & FDA aware)
  • Artwork & braille handoffs; micro‑text limitations respected
  • Market variants from a master IFU to EU/US/GCC/UKCA
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UDI & registry data

  • DI/PI fields (GS1/HIBCC), GTIN & barcode text, LOT/SN wording
  • Date formats and decimal separators by region
  • Copy harmonisation for GUDID/SFDA and other registries
playlist_add Map my UDI set task_alt Request signed bundle
library_books

CER / SSCP & PMS/PSUR

  • Reviewer‑friendly language with bilingual redlines
  • Signed PDFs and exportable change/audit logs
  • Clear, consistent terms via TermOps
mail Ask about evidence request_quote Include in quote
memory

SaMD/HMI UI (i18n & L10n)

  • Prompts, alarms and UI messages with truncation/nowrap controls
  • Plain, readable strings for field and clinic settings
  • String boards for easy review by engineers/HCPs
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Languages & markets for devices

gavel EU MDR/IVDR gavel US FDA gavel UKCA gavel GCC (Arabic)
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    Security & compliance

    • ISO 17100 & 27001 controls, SSO/RBAC, encrypted exchange
    • Least‑privilege access, time‑boxed reviewer links
    • PII handling aligned to enterprise policies
    rule View security pages qr_code_2 Request a signed bundle
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    Proof points

    • Reviewer‑independence on every deliverable
    • TermOps locks for stable vocabulary across markets
    • Bilingual redlines show exactly what changed
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    IFU / eIFU Pack Builder — panels, symbols & regional notes

    Drag symbols from the palette into the panel slots (Front, Back, Panel A/B). Switch region to see conflicts and required items. Toggle Braille when applicable and export a quick scoping summary.

    gavel 🇪🇺 EU (MDR) gavel 🇺🇸 US (FDA) gavel 🇬🇧 UKCA gavel 🏛️ GCC (AR)
    Front
    Back
    Panel A
    Panel B
    task_alt Summary
    warning 0 conflicts
    playlist_add_check 0 required missing
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    Selected outcomes

    Barcode and label macro for device packaging

    UDI multi‑market rollout (EU/US/UKCA)

    GS1/UDI attributes and label sets across regions with bilingual diffs and artwork cycles. Signed bundle delivered with change log and proofs.

    Read case
    Device PCB representing SaMD UI

    SaMD UI refresh (12 languages)

    Truncation handling, no‑wrap constraints and alarm string harmonisation. Delivered a strings board with diffs and a signed PDF for QA records.

    Read case

    FAQs for device teams

    Do you support MDR/IVDR expectations for IFU/eIFU and labeling?

    Yes. We align symbol sets, IFU/eIFU structure and labeling phrases to MDR/IVDR norms, including braille and artwork cycles where needed.

    How do you handle UDI data elements and region‑specific fields?

    We harmonise DI/PI terms, GTIN text spacing and date formats. Region switches (EU/US/UKCA/GCC) drive field requirements and micro‑phrasing.

    Can you prepare CER/SSCP and PMS/PSUR (devices) with reviewer evidence?

    Yes. We provide bilingual diffs, signed PDFs and audit logs so reviewers can follow changes easily.

    Do you work on SaMD/HMI UI with truncation constraints?

    We internationalise strings (i18n) and then localise (L10n) with truncation/no‑wrap rules and a test board to preview risks.

    How do you ensure security & auditability for device files?

    ISO 17100/27001 controls, SSO/RBAC and encrypted exchange. We can export an audit trail and signed bundles for each release.

    Which languages/markets do you cover?

    EN↔EU core, EN↔AR (GCC), EN↔Indian languages, EN↔APAC. Copy is adapted to MDR/IVDR, FDA 21 CFR and UKCA expectations.

    Ready when your timeline is

    Tell us what you need localised and when it must be review‑ or submission‑ready. We’ll adapt to your release cadence and provide the evidence your reviewers expect.

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