UDI / Medical Device Compliance Labeling

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.