Wrong revision in circulation.
A superseded IFU in a distributor's folder is a real risk. Nobody can say who still holds which version.
Use case · Illustrative scenario
01 · MEDICAL DEVICES
The right IFU, for the right country, in the valid revision.
A medical device manufacturer gives distributors, hospitals and its own sales team one controlled place for product data, instructions for use and declarations of conformity — entitled per distributor and country, reviewed before publication, logged on every access.
“Sixty distributors, fourteen languages — and every one of them must see only what is released for their country.”
02 · Today
Released in the QMS. Lost in the inbox.
The manufacturer produces medical devices and accessories in several risk classes — device families with sizes, versions, sterile and non-sterile variants, plus spare parts and consumables. Around 12,000 articles, sold directly in some countries and through about 60 distributors in others.
Instructions for use, declarations of conformity, certificates, labels and technical data are created and released under document control in the QMS. Product master data and UDI attributes live in the PIM and the ERP. Not every product is placed on the market in every country, and not every revision is valid everywhere at the same time.
Today, distributors receive documents by email or through a shared folder per country. Customer service answers the same questions every week: Which revision is valid? Is this product available in our market? Where is the declaration in Portuguese? Tender teams at hospitals ask for structured product data and certificates on short deadlines.
PIM Gate distributes what your QMS has released. Document control, regulatory decisions and registry submissions remain in your quality and regulatory processes.
| Content per market · example | varies by | source |
|---|---|---|
| IFU (PDF) | Country · language · revision | QMS · released |
| Declaration of conformity | Device family · regulation | QMS · released |
| Certificates | Notified body · validity date | QMS |
| UDI data | Packaging level | PIM / ERP |
| Market availability | Country | ERP / Regulatory |
03 · Challenges
Where regulated distribution gets risky.
Market availability is not visible.
Distributors see products that are not placed on the market in their country — and order or quote them.
UDI data travels by spreadsheet.
UDI-DI per packaging level, Basic UDI-DI, nomenclature codes and device attributes are compiled by hand for distributors and tenders.
Fourteen languages, one review standard.
Product texts need the same controlled review in every language; machine translation cannot go out unreviewed.
Every access must be traceable.
Quality and IT need to show who downloaded which document, in which revision, and when — for years.
Data residency is not negotiable.
Information security requires EU hosting as a minimum; Swiss or dedicated hosting is expected for some markets and customers.
04 · The setup
Released content in. Entitled, reviewed, logged content out.
PIM Gate reads released documents and their metadata from document control, product and UDI data from the PIM, and market availability from the ERP. It combines them per article, holds anything new or changed for regulatory approval, and only then publishes — to the distributor portal, the sales team, distributor feeds and the website. Each distributor sees only its countries; each download is written to an append-only log.
Diagram. QMS, PIM, ERP and translation memory feed PIM Gate. PIM Gate validates, translates, entitles and audits, holds new or changed content for regulatory approval, then publishes to a distributor portal, a sales and tender portal, distributor feeds and the website. All access is written to an append-only audit log. Hosting in Germany by default; Swiss or dedicated on request.
Where it runs
What one distributor sees
05 · Workflow
From QMS release to distributor download — with a gate in between.
- 01
Take only released content.
Document control exports released IFUs, declarations and certificates with revision, language, country and validity. Drafts never reach the gate.
- 02
One record per article.
Product and UDI data from the PIM, market availability from the ERP and the valid documents are linked per article and packaging level.
- 03
Product texts in 14 languages.
Short texts and attribute values are translated with your TM and termbase — by your translators via XLIFF packages or with an engine you choose per language, including EU-hosted models. Every language goes through a named reviewer. IFUs themselves stay in your controlled translation process.
- 04
Nothing new goes out unreviewed.
New or changed records and documents are held for review. Regulatory affairs approves publication; the approval is logged.
- 05
Each distributor sees its own shelf.
Access is scoped per distributor, country and role. Superseded revisions disappear from the portal the moment the new one is approved; feeds deliver the change as a delta.
- 06
Every access is logged.
Views, downloads and exports are written to the append-only audit log — optionally retained for ten years.
06 · Modules & portals
What this setup uses — and what is live today.
- LIVE
Ingestion XML · REST pull · scheduled SFTP
Released documents, PIM and ERP data
- LIVE
Canonical schema · attribute metadata (type, unit, locale, market flags)
UDI attributes and market availability per country
- LIVE
Customer Portal as distributor portal
Entitled browsing and document download
- 2026
RBAC roles & groups · admin console
Distributor admin/user, sales, tender, reviewer
- LIVE
Validation rules · review hold before publication
Regulatory approval gate
- 2026
Product-data translation with review queue
14 languages, per-language reviewer, engine per language
- 2026
Sales Portal
Customer-specific XLSX/PDF for tenders
Append-only audit log · audit UI
Traceability of every access
Log live · UI 2026
Audit-log retention 10 years
Long-term traceability
Add-on
- LIVE
Versioned REST API /v1 · delta sync
Distributor feeds, website IFU lookup
- ON REQUEST
Swiss data centre
Hosting option
- ON REQUEST
Dedicated instance / on-prem
Enterprise hosting option
- ROADMAP
SSO OIDC/SAML · MFA
Staff and distributor sign-on
07 · Expected effects
What typically changes.
Indicative
Documents in country folders → One portal that shows only the valid revision per country and language.
Indicative
Distributors see everything → Distributors see only products placed on the market in their countries.
Indicative
UDI data compiled by hand → UDI data delivered per article and packaging level via portal, export or API.
Indicative
Unreviewed translations → Every language reviewed by a named person before publication.
Indicative
“Who has which version?” → Every view and download in an append-only log.
Indicative
Hosting as an open question → Germany by default; Swiss or dedicated hosting on request.
Qualitative expectations for this scenario, not measured results. PIM Gate supports your processes; responsibility for regulatory content and its release remains with the manufacturer.
08 · Typical configuration
Version L, two portals, long audit retention, a full-size test tenant.
Fourteen languages require Version L (unlimited languages). Regulatory affairs, product management, sales, tender office and customer service add up to 26–100 seats. Distributors and their staff are portal users — unlimited. A test tenant at full capacity lets quality and IT test changes against production-size data before they go live. Indicative list price €31,800 per year.
Options
- Swiss data centre hosting: on request
- Dedicated instance or on-prem: on request (enterprise)
- Premium support beyond Version L SLA: on request
| Item | € / year |
|---|---|
| Version L — 26–100 seats, ≤ 500k SKUs, all 3 portal modules, unlimited languages, 99.9% SLA | €20,400 |
| Customer Portal (distributors) + Sales Portal (tenders) — included in L | incl. |
| Audit-log retention 10 years | €1,200 |
| Stage/test tenant · full capacity (50% of Version L) | €10,200 |
| Indicative list price | from €31,800 |
09 · Rollout
Security review first, then two pilot countries.
- 01
Weeks 1–4 · Scope & review
Weeks 1–4Scoping, security and contracts. Hosting decision (Germany, Swiss, dedicated), DPA, information security questionnaire, entitlement model per distributor and country, document metadata required from document control.
- 02
Weeks 5–10 · Build & test
Weeks 5–10Connect and model in the test tenant. QMS export, PIM and ERP ingestion, UDI attributes, review hold and publication rules; quality and IT test with production-size data.
- 03
Weeks 11–16 · Pilot
Weeks 11–16Two countries, a handful of distributors. Distributor portal live for a pilot group; translation and review for the pilot languages; audit log reviewed with quality.
- 04
From week 17 · Roll out
From week 17Country by country. Further distributors and languages in waves; sales and tender portal; distributor feeds via API.
Indicative plan for this scenario. Regulated projects depend on your internal review and approval cycles.
10 · Next step
Recognize your setup? Book a scoping call.
Bring your distributor list and one document family. We sketch the entitlement model, the review hold and the hosting option that fits your security requirements.
11 · Keep reading
More on this scenario
Security, sovereignty & trust
Hosted in the EU or Switzerland, tenant-isolated, audited.
2026
Roles, rights & entitlements
Access scoped per distributor, country and role.
LIVE
Customer Portal
Self-service for everyone who asks for your data.