FOR MEDICAL DEVICE MANUFACTURERS
Your product documents.One connected portal.
Medical device document portal & QR access
Healthcare professionals and patients can find relevant documents using a product reference, GTIN or QR link. Your team manages product–document mapping and controlled publication in the same platform.
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How do you find the correct IFU by reference or GTIN?
A document portal connects product identifiers with published document records. Select the correct product first, then assess audience, country and document language. Finding a product in search does not mean a current IFU has been published in every language for that product.
Access to a PDF file and controlled eIFU publication involve different responsibilities. Before defining your requirements, review the difference between eIFU and PDF hosting.
Example: from product SAMPLE-001 to its English IFU
SAMPLE-001 is a fictional product reference. This example uses no customer record or registered GTIN. Suppose English IFU Rev. B has been published for the product’s relevant audience and country scope.
- 01
Find and check the product
Search using the product reference or the GTIN recorded in your inventory. Check the product name and identifier in the results; do not select another product with a similar code. A product-specific QR can open the relevant product record directly.
- 02
Select audience, country and document language
Select the relevant audience and country, then choose English as the document language. A Turkish interface does not prevent selecting an English file; interface language and file language are assessed separately.
- 03
Verify the opened file
Check product, document type, file language and revision in the current document list. The example should open English IFU Rev. B. If the requested version is unavailable, do not treat another product’s or language’s file as equivalent.
Three distinct records in product–document mapping
- Product record
- Product name, reference/REF and GTIN where available. Keep identifiers accurate in your inventory; entering a GTIN alone does not validate the product or document content.
- Document and revision
- Document type, file language, revision and publication status. A file’s title alone does not determine which product’s users should receive it.
- Publication scope
- Mapped products, intended audience and country/market scope. When one document is mapped to several products, check each mapping separately.
Direct answers about medical device document portals
What is the difference between reference and GTIN search?
REF is the manufacturer’s product reference; GTIN is stored as a separate product identifier in the inventory. eIFU Systems search can find results using the recorded reference, product name or GTIN. Check that the result is the correct product.
What if the product appears in search but no IFU is available?
Check the selected product, audience, country and file language. Search results and published document listings are distinct; a current file may be unavailable for that scope. Follow the manufacturer’s support process.
Does selecting an audience verify the user’s identity?
No. Selecting patient or healthcare professional scope in the portal is a document presentation choice; it does not establish the user’s profession or identity.
Will a draft IFU appear in the current document list?
The current list offers published versions in the selected language. A draft or merely approved file is different from a document published in the portal. Previous or withdrawn versions are assessed separately in document history.
Check product–IFU mapping in five situations
This fictional SAMPLE-001 checklist helps you compare portal results with the underlying records. Repeat the checks in a demonstration environment with your chosen product, audience, country and file language.
Correct product and published English IFU
The product name and reference match; English Rev. B is published for the selected scope. Open it from the current list and check the file’s product, language and revision.
Another product with a similar reference
A search result shows another product with a similar reference instead of SAMPLE-001. Do not treat its document as equivalent; select the correct record using the product name and full reference.
No file in the requested language
The correct product may have an English IFU but no publication in another selected language. Changing the interface language does not create a translation. Do not treat another language’s file as the requested version; follow the manufacturer’s support process.
Same product, different publication scope
Changing audience or country may change the offered documents. Do not assume that an IFU shown for one scope is also offered for another; check each selection separately.
Latest version has been withdrawn
If Rev. B is withdrawn, check its status and reason in history. Do not expect Rev. A to become current automatically; follow the manufacturer’s support process when no current document is available.
Product mapping checks for your demonstration
- Find the same correct product using its full reference and recorded GTIN.
- Compare product names and document mappings for similar product codes.
- Check the same product with patient/healthcare professional, country and file language selections.
- Test the absence of a document in the requested language in a test environment too.
- Verify the product QR, document type and opened revision against the same record.
Explore the eIFU software selection guide →
Explore the multilingual IFU example →
Discuss your product search and document scope ↗