イメージプレビュー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.
UDI / Medical Device Compliance Labelingとは？
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.
主な機能
受注生産、すべておまかせ
自分での設定は不要 — ECOSIRE が構築・インストール・サポートする実働アプリです。
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ご注文
一回限りの構築料金から始めます。キックオフで一緒に範囲を決めます。
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構築とインストール
ECOSIRE がお客様の Dynamics 365 Business Central 上で構築・設定・インストールします。
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本番稼働 + サポート
約1週間（営業日ベース）で稼働し、本番稼働後2週間のサポートが付きます。納品したコードの不具合は無償で修正します。
この製品について
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.
得られるもの
- 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
これは誰のためのものですか
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 の比較方法
| 基準 | エコシエール | カスタムビルド | 競合他社 | Dynamics 365 Business Central 標準機能 |
|---|---|---|---|---|
| FDA GUDID-ready (HL7 SPL) record assembly | 付属 | 部分的なサポート | 部分的なサポート | 含まれていない |
| EU MDR EUDAMED-aligned device data export | 付属 | 部分的なサポート | 部分的なサポート | 含まれていない |
| UDI-DI/UDI-PI GS1-128 / Data Matrix carrier generation | 付属 | 部分的なサポート | 付属 | 含まれていない |
| Built on native item-tracking lot/serial/expiry data | 付属 | 部分的なサポート | 部分的なサポート | 部分的なサポート |
| Built, installed per-tenant and supported on your environment | 付属 | 部分的なサポート | 含まれていない | 含まれていない |
| Tailored to your issuing agency, device classes and label stock | 付属 | 付属 | 含まれていない | 含まれていない |
| Regulatory document control with version/audit trail | 付属 | 部分的なサポート | 部分的なサポート | 含まれていない |
| REST/OData API + Dataverse/Power Platform integration | 付属 | 部分的なサポート | 部分的なサポート | 部分的なサポート |
UDI / Medical Device Compliance Labeling に関するよくある質問
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