示意预览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.
什么是 UDI / Medical Device Compliance Labeling？
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 $999.00 USD; request a quote for a scoped proposal.
核心功能
按需定制，全程代劳
无需自行搭建——由 ECOSIRE 构建、安装并提供支持的可用应用。
- 1
您下单
以一次性构建价格开始。我们在启动时与您共同确定范围。
- 2
我们构建与安装
ECOSIRE 在您的 Dynamics 365 Business Central 上构建、配置并安装。
- 3
上线 + 支持
约一个工作周内上线，并包含两周上线支持。我们交付的代码中的缺陷免费修复。
关于此产品
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.
你得到什么
- A per-tenant Business Central AL extension (.app) built for your environment, installed and published to your tenant by ECOSIRE
- Device Master configuration seeded with your issuing agency, GMDN/EMDN codes and device classes
- Configured UDI label layouts (GS1-128 / Data Matrix) matched to your label stock and printers
- Custom API pages exposing device and submission records over REST/OData for GUDID/EUDAMED integration
- Permission sets and Job Queue setup for label, validation and submission batch runs
- Handover documentation: data dictionary, label spec, submission-mapping reference, and admin runbook
- A validation/UAT cycle against a sample of your real devices before go-live
- Post-go-live support window with bug fixes and regulatory-mapping adjustments
这是给谁的
Regulatory / Quality Affairs Manager
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.
Manufacturing / Operations Lead
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.
ERP / IT Administrator
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.
UDI / Medical Device Compliance Labeling 如何比较
| 标准 | 伊科西尔 | 定制建造 | 竞争对手 | Dynamics 365 Business Central 原生 |
|---|---|---|---|---|
| FDA GUDID-ready (HL7 SPL) record assembly | 包含 | 部分支持 | 部分支持 | 不包括在内 |
| EU MDR EUDAMED-aligned device data export | 包含 | 部分支持 | 部分支持 | 不包括在内 |
| UDI-DI/UDI-PI GS1-128 / Data Matrix carrier generation | 包含 | 部分支持 | 包含 | 不包括在内 |
| Built on native item-tracking lot/serial/expiry data | 包含 | 部分支持 | 部分支持 | 部分支持 |
| Built, installed per-tenant and supported on your environment | 包含 | 部分支持 | 不包括在内 | 不包括在内 |
| Tailored to your issuing agency, device classes and label stock | 包含 | 包含 | 不包括在内 | 不包括在内 |
| Regulatory document control with version/audit trail | 包含 | 部分支持 | 部分支持 | 不包括在内 |
| REST/OData API + Dataverse/Power Platform integration | 包含 | 部分支持 | 部分支持 | 部分支持 |
关于UDI / Medical Device Compliance Labeling的常见问题
How long does delivery take, since this isn't an instant AppSource download?
Typical build-to-order lead time is one working week 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.
Is this an AppSource app I can just install myself?
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.
Does ECOSIRE submit my devices to GUDID and EUDAMED for me?
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.
How are ongoing support and Business Central updates handled?
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).
Will this conflict with our existing customizations or core Business Central?
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.
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UDI / Medical Device Compliance Labeling
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.
- Device Master record table (new AL table) holding UDI-DI, GMDN/EMDN code, issuing agency (GS1/HIBCC/ICCBBA), risk class, and sterilization/single-use flags
- UDI-DI / UDI-PI barcode label generation as GS1-128 or GS1 Data Matrix carriers, rendered to your label stock and printer
- Table extensions on Item, Lot No. Information and Serial No. Information to carry UDI-PI production identifiers (lot, serial, mfg date, expiry)
- Lot/serial and expiry traceability built on Business Central's native item-tracking engine — no parallel ledger