CASE STUDY
From Napkin Sketch to FDA Pre-Submission in Under Four Months
A 16-document FDA Pre-Submission package, built in under four months.
A pre-submission with no time to spare
An early-stage AI-enabled SaMD company went from a product concept and early models to a defined device, regulatory strategy, and a 16-document FDA Pre-Submission package in under four months. QualiVerse connected product definition, user needs, performance criteria, validation planning, quality, and regulatory strategy around one product definition, helping the team reach alignment with FDA on its initial device classification just five days after written feedback.
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An early-stage AI-enabled SaMD company went from a product concept and early models to a defined device, regulatory strategy, and a 16-document FDA Pre-Submission package in under four months. QualiVerse connected product definition, user needs, performance criteria, validation planning, quality, and regulatory strategy around one product definition, helping the team reach alignment with FDA on its initial device classification just five days after written feedback.