A build-to-order Business Central extension that generates compliant UDI-DI/UDI-PI labels, manages device master records, and prepares GUDID and EUDAMED submissions — built, installed per-tenant and supported by ECOSIRE on your environment. Built to order by ECOSIRE for Dynamics 365 BC (build-to-order) — indicative price from $799.00 USD; request a quote for a scoped proposal.
ایپ مینی فیسٹ
آپ کے ورک فلو کے مطابق تیار کردہ
A build-to-order Business Central extension that generates compliant UDI-DI/UDI-PI labels, manages device master records, and prepares GUDID and EUDAMED submissions — built, installed per-tenant and supported by ECOSIRE on your environment.
خود سیٹ اپ کی ضرورت نہیں — ایک کام کرنے والی ایپ جو ECOSIRE بناتا، انسٹال اور سپورٹ کرتا ہے۔
ایک بار کی تعمیر کی قیمت سے آغاز کریں۔ آغاز پر ہم آپ کے ساتھ مل کر دائرہ کار طے کرتے ہیں۔
ECOSIRE اسے آپ کے Dynamics 365 Business Central پر بناتا، ترتیب دیتا اور انسٹال کرتا ہے۔
آپ تقریباً 2–4 ہفتوں میں لائیو ہو جاتے ہیں، لانچ کے بعد معاونت کی مدت کے ساتھ۔
UDI / Medical Device Compliance Labeling is a custom-built AL extension for Microsoft Dynamics 365 Business Central that brings FDA and EU MDR Unique Device Identification into the same system you already run production, inventory and shipping in — instead of a spreadsheet plus a third-party labeling tool.
ECOSIRE designs, builds, installs and supports this as a per-tenant extension deployed directly to your Business Central environment (cloud SaaS or on-prem). It is not an instant AppSource download — it is engineered around your device portfolio, issuing agency (GS1, HIBCC or ICCBBA), label stock and regulatory workflow, then handed over installed and working.
What it does. A new Device Master table extension holds each device's UDI-DI, GMDN/EMDN code, issuing agency, sterilization and single-use flags, and risk class. Table extensions on Item, Lot No. Information and item tracking carry the UDI-PI data elements — lot/batch, serial number, manufacturing date and expiry — so traceability uses Business Central's native item-tracking engine rather than a parallel ledger. Page extensions surface everything in familiar Item and Lot cards; a dedicated label action renders GS1-128 / Data Matrix UDI carriers to your label format.
Submissions. The extension assembles GUDID-ready records (FDA HL7 SPL structure) and EUDAMED-aligned device data, validates required attributes before release, and exposes them through Business Central's REST/OData API so they can flow to your GUDID submission account or EUDAMED actor — with a regulatory document-control register tracking versions, approvals and audit trail. Permission sets scope who can edit device records versus release submissions; the Job Queue handles batch label and validation runs.
Honest scope: ECOSIRE builds the integration and data layer; final regulatory sign-off and account submission remain your quality team's responsibility.
Owns FDA UDI Rule and EU MDR compliance; needs every marketed device to carry a valid UDI and to have current GUDID/EUDAMED records, with an auditable trail proving it.
Runs production and labeling on Business Central and wants UDI carriers printed from the same item-tracking and lot data already captured, without a separate labeling silo.
Maintains the Business Central tenant and prefers a supported per-tenant extension with clean permission sets and APIs over unmanaged custom code or risky core modifications.
| Criterion | ECOSIRE | Custom Build | Competitor | Odoo Native |
|---|---|---|---|---|
| FDA GUDID-ready (HL7 SPL) record assembly | Included | Partial support | Partial support | |
| EU MDR EUDAMED-aligned device data export | Included | Partial support | Partial support | |
| UDI-DI/UDI-PI GS1-128 / Data Matrix carrier generation | Included | Partial support | Included | |
| Built on native item-tracking lot/serial/expiry data | Included | Partial support | Partial support | |
| Built, installed per-tenant and supported on your environment | Included | Partial support | Not included | |
| Tailored to your issuing agency, device classes and label stock | Included | Included | Not included | |
| Regulatory document control with version/audit trail | Included | Partial support | Partial support | |
| REST/OData API + Dataverse/Power Platform integration | Included | Partial support | Partial support |
Typical build-to-order lead time is 3 to 6 weeks from kickoff, depending on the number of issuing agencies, device classes and whether GUDID, EUDAMED or both are in scope. The flow is: discovery and data mapping, AL development, installation of the per-tenant extension on a sandbox, a UAT/validation cycle against your real devices, then production go-live. You get progress checkpoints throughout — nothing is downloaded blindly from a marketplace.
No. It is a per-tenant AL extension that ECOSIRE builds for your device portfolio and installs directly to your Business Central environment (cloud or on-prem). This is deliberate — UDI data, issuing-agency setup and submission mapping are specific to each manufacturer, so a generic one-click app would not produce compliant records without configuration. We handle the build, publish and install for you.
The extension assembles, validates and exports GUDID-ready (HL7 SPL) and EUDAMED-aligned records and exposes them via the REST/OData API, so submission becomes a controlled, repeatable step. Final regulatory review and the actual submission to your FDA GUDID account or EU EUDAMED actor remain your quality team's responsibility — we provide the compliant data and the integration plumbing, not regulatory sign-off.
Every build includes a post-go-live support window for bug fixes and regulatory-mapping adjustments. Because it is a managed AL extension, it follows Business Central's standard update lifecycle; ECOSIRE offers an ongoing maintenance arrangement to recompile and revalidate against each major Business Central release and to track changes in FDA UDI or EU MDR data requirements (for example new EMDN codes or EUDAMED field changes).
No. It is implemented with table extensions, page extensions and event subscribers — the supported AL extensibility model — so it never modifies the base application. It coexists with other extensions, uses its own permission sets, and can be uninstalled cleanly. During discovery we review your existing customizations to avoid event or field collisions before any code is written.
A build-to-order Business Central extension that generates compliant UDI-DI/UDI-PI labels, manages device master records, and prepares GUDID and EUDAMED submissions — built, installed per-tenant and supported by ECOSIRE on your environment.