Greenlight Guru publishes that it is the only QMS platform designed by medical device professionals specifically and exclusively for the medical device industry. That focus is why they are good at it. If you are audited against AS9100 or AS9120, you want the same focus pointed at your standard.
This is not a page about who is better. It is about which regulator each product was built around, in each company's own published words.
Every one of these is live today. Every one files a record you can hand to an auditor.
The AI reads. A rules engine decides. That split is what makes the output defensible evidence instead of an opinion.
Drop in the whole receiving package. It classifies 17 document types, runs about 40 checks, validates the CAGE code against SAM.gov, tests the source against your own approved supplier list, and cites every finding to the standard and to your customer's flow-down.
It reads the paperwork, not the parts. The review that ate an afternoon takes minutes, and a named human still signs the disposition.
Attach the drawing and ask. It balloons every accountable characteristic per AS9102 Rev C and drafts the forms into a numbered record.
You do not fill out a form. You ask, and the first article builds itself.
Check your first article before your customer does. Including the characteristic count mismatch that bounces most packages.
Catch the rejection at your desk instead of at theirs.
Screens a party against the U.S. Consolidated Screening List, walks the ITAR and EAR fork, and files the determination once a qualified person signs.
It never clears a party on its own. A named human signs, and the record proves it.
Procedures, audit plans, corrective actions, management review packs, system security plans, job hazard analyses, end user statements.
Drafted against the standard you hold, in your language.
Every morning it hands you what needs you today. Reviews due, acknowledgments unsigned, findings about to breach, training about to expire.
Thirty seconds instead of twenty minutes of digging.
The second time is always faster than the first, because the system already knows the answer and who signed it.
You classify a part. The platform walks the ITAR and EAR fork, proposes the determination, and files it the moment a qualified person signs off. Minutes.
Six months later somebody types the bare part number in a brand new conversation. Back comes the determination, the signer and the date. Seconds, and nothing re-derived.
Specialisation is the right strategy. It is only the wrong purchase when you are not the specialisation.
You do not need a deeper medical device platform. You need that same depth aimed at aerospace paperwork.
Every line on the left is what Greenlight Guru publishes about itself. We make no claim about what their software can or cannot do.
Published as designed by medical device professionals specifically and exclusively for the medical device industry.
Built by a quality compliance auditor with close to two decades in aerospace, defense and manufacturing.
Published standards are ISO 13485, 21 CFR Part 820, QMSR, EU MDR, ISO 14971 and IEC 62304.
AS9100D, AS9120, ISO 9001, ITAR and EAR, CMMC and NIST 800-171, and your customer's own flow-down.
Design controls and the design history file are central to the product.
Receiving inspection, first article and traceability are central, because that is where the risk sits in a distributor or build-to-print shop.
Their published customer base is medtech.
Built for the aerospace distributor whose standard does not appear on any major eQMS standards list we checked.
All new customers must purchase one-time onboarding services to get started.
Your environment is stood up against your standard before the demo, and that is what you evaluate.
If you build medical devices, their fit is better than ours and we will say so on the call.
Not a general purpose AI tool with a compliance label stuck on the front.
I have written the corrective action, and I have been the one who rejected it. That is the difference between a tool that sounds right and one that survives contact with an auditor.
Omie Trikha, founder, QMS Leader
Nearly two decades implementing and auditing quality systems for aerospace, defense, and manufacturing. Every play in it came off a real floor.
Built on a commercial AI agreement that contractually bars the provider from training on your data. Not a setting somebody has to remember to switch off.
AS9100D, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO 27001, CMMC and NIST 800-171, ITAR, FDA 21 CFR 820, OSHA.
The dashboard and the evidence package were built for the person who has to hand something to a registrar, not for a marketing page.
Everything below is included. Nothing below is an upsell.
This is the first question every quality director asks, so it gets answered before you book anything. Send your security questionnaire ahead of the demo and we will return it completed, line by line.
The one you would have escalated. We run it live and you judge the verdict against the call you would have made.