How does labeling data relate to a regulatory submission?

The data printed on a label and the data submitted to a regulator describe the same product, so they should originate from one record. When they are maintained separately (the label in a design tool, the submission in a spreadsheet) they drift, and the discrepancy surfaces either as a rejected submission or as an inspection finding. Sourcing both from a single validated product record removes the reconciliation work and the risk.

Topic

Regulatory submissions

Preparing and submitting device and product data to GUDID, EUDAMED and equivalent registries without maintaining parallel spreadsheets.

2 articles on Regulatory submissions.

Updated October 18, 2023

Innovatum- Platinum Sponsor Of the Q1 11th Annual Medical Device & Diagnostic Labeling Conference

Innovatum Sponsors yet another Q1 Conference. Find our more about conference involvement.

Updated July 27, 2023

A Risk Based Approach To 510(k) Cumulative Review For Medical Devices

Creating a link between Medical Device Reporting, Risk Management, & 510(k) Cumulative Review allows manufacturers to create assurances of safety..

Regulatory submissions

2 articles on Regulatory submissions.

Innovatum- Platinum Sponsor Of the Q1 11th Annual Medical Device & Diagnostic Labeling Conference

A Risk Based Approach To 510(k) Cumulative Review For Medical Devices

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