For MedTech Companies

Get to Market Faster with Fewer Revision Cycles

Stop waiting months for Notified Body feedback only to discover compliance gaps. Our AI audit simulator catches issues at the draft stage—before they become costly delays.

Sound Familiar?

MedTech companies face the same regulatory challenges over and over.

⏱️

Months of Back-and-Forth

Multiple revision rounds with Notified Bodies, each taking weeks to process.

💸

Costly Late-Stage Surprises

Discovering compliance gaps after submission means expensive rework and delays.

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Overwhelming Requirements

EU MDR, ISO 13485, ISO 14971—thousands of requirements to track manually.

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Inconsistencies Slip Through

Human reviewers can't catch every inconsistency across hundreds of pages.

RegCheck Changes the Game

Pre-submission compliance screening that catches gaps before they cost you time and money.

Submit Drafts Early

Upload documentation at any stage. Get feedback before it's too late to make changes easily.

Exhaustive AI Review

Our AI checks thousands of requirements—not samples—finding gaps humans miss.

Actionable Reports

Clear compliance scores, specific gaps identified, and exportable results for your team.

Results That Matter

40%
Faster Audit Preparation
66%
Fewer Late-Stage Non-Compliances
1
Maximum Review Round

Ready to Accelerate Your Certification?

See how RegCheck can reduce your time-to-market and cut revision cycles.