Conformity Verification

Drive FDA Verification of Conformity, UDI creation, and GUDID submission cleanly, without the last-minute scramble.

Overview

Verification of Conformity, UDI, and GUDID are not regulatory headline work but they will stop a launch cold if done late. The data is fiddly, the agency portals are unforgiving, and the timing intersects with product release windows.

We do the back-office work: issuing agency setup, UDI structure, DI/PI definitions, GUDID submission, and ongoing GUDID record maintenance.

Our Process

  1. 1

    Issuing agency selection

    GS1 or HIBCC; documented rationale.

  2. 2

    UDI structure design

    DI / PI components mapped to product configurations.

  3. 3

    GUDID account & submission

    Account setup, primary user, draft submission with QA review.

  4. 4

    Production cutover

    UDI on labels, packaging, and electronic records.

  5. 5

    Ongoing maintenance

    GUDID record updates as the product evolves.

Frequently Asked Questions

Does this cover EU UDI (EUDAMED)?

Yes, coordinated with FDA UDI to minimize duplicate effort.

What about Class I exempt devices?

Same fundamental work, simplified GUDID requirements.

Can you train our team to maintain ongoing?

Yes, handover after the initial GUDID publication.

How long does first GUDID publication take?

Typically 6-10 weeks from kickoff.

Clear the back-office work before launch.

Tell us your product launch timeline. We will return a Verification of Conformity plan within five business days.

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