Greenlight Guru
The medical device platform that lowers audit risk by 3.5x
By Greenlight Guru · 4.0/5 verified-buyer score
Positioning guardrails
Best for
- Medical device startups building their first FDA-submission-ready quality system
- Class II/III device makers that need design controls and DHF traceability in one connected system
- SaMD, IVD and diagnostics teams that want an eQMS purpose-built for medtech
- Quality and regulatory leaders who must stay audit-ready for ISO 13485 and MDSAP inspections
Ideal size: 10–500 people · Medtech startup through scaled device manufacturer with an active regulatory obligation
Not for
- Companies outside medtech that need a general-purpose QMS
- Buyers who require published list pricing before talking to sales
- Teams whose quality processes are not governed by FDA/ISO 13485-style device regulation
Value metrics scorecard
Time-to-Value
8–12 weeks (guided implementation)
~90 days to first production value
Total Cost of Ownership
$0/yr
Starts at $0 · Quote-based; pricing varies by solution (Greenlight Guru Quality or Clinical) and company size. The pricing page directs buyers to sales rather than listing rates.
Implementation Friction
3/5
Engineering + admin effort required
Buyer Score
out of 5 · verified buyers
Full cost breakdown
Mandatory implementation fee
None
Seat tiers
Not published
Add-on costs
- None
Company & support
Who is behind Greenlight Guru, and how your team gets help once it is live.
Market position
Where Greenlight Guru sits relative to every other solution in the database. Toggle axes to compare on cost, speed, friction, or buyer score.
Quadrant view
Typical annual cost × Time-to-value
Stack fit signal
Compatibility with standard B2B ecosystems.
No supported MCP path today, so it cannot be driven from an AI client.
AI & MCP readiness
What Greenlight Guru ships in AI, and what it asks of your ecosystem.
AI features shipped
Vendor describes AI chat over QMS data to summarize content and spot patterns, AI-powered global search returning direct answers with linked source references, AI brainstorming for design controls and risk, predictive verifiability checks, and plain-language training analytics returned as charts. Model sourcing and AI action logging are not documented.
In your ecosystem
- AI connection
- Not supported
- Model key
- Not recorded
- AI usage audit
- Not recorded
Industry verdicts
How Greenlight Guru speaks to each vertical it serves — same data, sector lens.
HealthcareMore patients, less paperwork.
Best for in Healthcare
- Medical device manufacturers needing design controls, DHF traceability and CAPA in one system
- Clinical study teams collecting EDC data from first-in-human through post-market
- Regulatory affairs teams preparing 510(k) submissions, CE marking and MDSAP audits
Not for
- Hospitals and clinics looking for general clinical or EHR software
- Life-science organisations outside device regulation that need a generic QMS
Greenlight Guru is built exclusively for medtech: the vendor reports 1,100+ device company customers, 2,000+ ISO 13485 certifications and 1,700+ 510(k) clearances and CE markings achieved by users. The platform spans quality management, product development with design controls and risk, and clinical data capture (EDC), so device makers can run quality, development and evidence in one regulated system rather than stitching tools together.
Compliance attestations
* IAPP AIGP certifies individuals, not products. It means named staff hold the credential — not that the platform does.
Bottom line
Greenlight Guru is a quality management system purpose-built for medical device companies, combining quality processes, product development with design controls, and clinical data capture in one platform. The vendor reports 1,100+ medtech customers, 2,000+ ISO 13485 certifications and 1,700+ 510(k) clearances and CE markings among users. Guided implementation targets weeks, not months, to first value. Pricing is quote-based and not published, and no security or trust page was available in the sources, so platform certifications remain unverified.
Frequently asked questions
What does Greenlight Guru cost?
The vendor does not publish rates. Its pricing page states that Greenlight Guru offers a range of pricing options for medtech companies of every size and stage, separated into the Quality solution and the Clinical (trial data collection) solution, with a prompt to talk to a Greenlight Guru expert for the right package. Budget holders should expect a quote-based, sales-led evaluation rather than self-serve checkout.
How long does it take to get to first value?
Greenlight Guru positions guided implementation as measuring time-to-value in weeks rather than months or years, working through a personalised implementation plan. Customer evidence on the site includes building an audit-ready QMS in three months and cutting audit preparation from weeks to hours. There is no published fixed implementation timeline or fee.
Is this a general QMS or something medical-device specific?
It is purpose-built for medical devices and diagnostics rather than a general-purpose QMS. Modules cover design and development with traceability between design inputs, outputs, verifications and risk controls, compliance and risk management, documents and training, quality events and CAPAs, and clinical data management through the Greenlight Guru Clinical product.
What AI capabilities are included?
The vendor describes an AI chat over QMS data to summarise content and spot patterns, AI-powered global search that returns direct answers with linked source references, AI-generated ideas for design controls and risk, predictive verifiability checks, and plain-language training analytics returned as charts. The sources do not state which model provider is used or whether AI actions are logged, so those should be confirmed with the vendor.
Can it manage clinical trial data as well as quality?
Yes. Greenlight Guru Clinical is a separate solution for electronic data capture, used for compliant, audit-ready clinical data from first-in-human studies through post-market activity. Customer stories on the site cover MDR-compliant prospective and retrospective studies, eCRF setup, and survey-style data collection.
Which regulatory frameworks does it support?
Customers publicly describe ISO 13485 certification and recertification audits, MDSAP audits, 510(k) clearances and CE marking with the platform, and the vendor aggregates these outcomes. Note that the available sources do not include a security or trust page, so the vendor's own SOC 2, ISO 27001 or similar platform certifications could not be verified here.