Greenlight Guru
👤 Jon Speer & David DeRam (Speer: 16+ yrs medtech QA, ran a QMS consultancy, and hosted the field's top podcast - the audience was already his.)🌐 siteLinkedIn
A cloud quality system built only for medical devices - the one tool FDA and ISO force every device maker to buy.
Will it work? · our read
Law forces demand. The FDA and ISO force every device maker to run a QMS. Greenlight Guru didn't create demand - it verticalized a legal mandate and let an insider's podcast do the selling.
01How the money moves
To sell a device, a maker must run an FDA/ISO quality system
→
They adopt Greenlight Guru's pre-built medtech eQMS
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Pay a 5-figure yearly subscription, renewed at every audit
02The numbers
1,000+Statedmedical device companies
the sentence on the page
2,000+ ISO 13485 certifications 1,200+ clinical trials 50% Completed You're Almost There... Trusted by 1000+ Medical Device companies Explore the Greenlight Guru Platform Built exclusively for…
The regulation deadline is a demand tailwind, not a headwind. FDA QMSR
Private (PE-backed). Est about $20-30M ARR; $120M raised from JMI (2021).
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You have the verdict. Members get the work behind it.
- The CENTS scorecard — where it's strong, where it's soft
- The founder's key move, and the counter-move
- How it could die — the evidence, and how sure we are
- The case against our own call
- A 🚀 launchpad prompt — the case, as a plan for your business
We rate our own confidence — and argue against ourselves. Nobody else in this category does.
Sources always public on all 560 cases · cancel anytime · 14-day refund
See a full teardown, free → ImportYetiSourcesSources last checked 25 August 2026
FDA - Quality Management System Regulation (QMSR) - the law that forces the demand; effective Feb 2, 2026.Covington - FDA finalizes QMSR, harmonizing 21 CFR 820 with ISO 13485.Global Medical Device Podcast - the founder-hosted content engine behind distribution.Company history - founded 2013; $120M from JMI; 1,200+ customers (Oct 2023).Latka - third-party revenue estimate (unverified; figures vary widely).
Revenue is EST, not disclosed: Greenlight Guru is private (PE-backed by JMI) and publishes no ARR. Third-party trackers disagree wildly - Latka about $16M, Zippia about $21M, Growjo about $33M - so treat "about $20-30M" as a rough band, not a fact. The only first-party numbers are disclosed funding ($120M from JMI, 2021) and 1,200+ customers (company-stated, Oct 2023). The vertical-only focus and founder-hosted podcast are documented facts; the bundling / FDA-ISO-harmonization death scenario is our read [infer], not a reported event. No drama fabricated. We never score you.