The new QMSR regulation is live. 56% of inspected companies already received Form 483 observations. Find your gaps before the inspector does — in 10 minutes, for free.
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// The Problem
Greenlight Guru, MasterControl, Veeva — built for 500-person companies, priced to match. A 5-person startup can't justify that.
The old "protected" records are gone. Management reviews, supplier assessments, internal audits — inspectors can see all of it now.
Hundreds of companies have years of documentation under the old standard. Every single document needs to be re-mapped. Nobody offers an affordable way to do this.
ISO 13485 has 8 sections, dozens of clauses, and requires everything to be connected. First-time founders and lean QA teams get lost immediately.
// The Solution
28 items covering all 8 sections of ISO 13485. See exactly where you stand right now.
Answer 30 questions about your current QMS. Our AI generates a personalized gap analysis with prioritized action items.
Get SOP templates, CAPA forms, risk management files — all pre-mapped to ISO 13485 clauses and inspection-ready.
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// Pricing
Free checklist. No credit card. Takes 2 minutes.
Medrify AI · Not legal advice · For informational purposes only