Greenlight Guru review

About the price: Vendor-published entry price for eQMS packages (Sep 2026); users and modules at that price not stated. Implementation is priced separately. Buyers report $21k–55k/yr (Vendr) and about $30k in year one for a 40-person team (2025).

What is Greenlight Guru?

Greenlight Guru is an Indianapolis software company, founded in 2013, that builds quality management software only for medical device companies.¹² It says it serves more than 1,100 of them.³ JMI Equity invested more than $120 million in 2021.⁴ Built In lists about 140 employees.¹

The product has two halves:²

• eQMS: document control, change control, training, suppliers, audits, CAPA, complaints and nonconformances.
• Product development: requirements, design controls, ISO 14971 risk and software releases.

A separate EDC product, from the 2022 SMART-TRIAL acquisition, handles clinical studies.³ In 2025 Greenlight Guru bought Enzyme, another QMS vendor.⁵ It also markets Ultralight, an eQMS for product-led, software-driven teams.⁶⁷ The company is also widely known for its free blog, podcast and academy.³

Who Greenlight Guru is for

It fits best for device companies of roughly 10 to 50 people that are preparing a 510(k) or CE mark, or have just made it, and want design controls, risk and the QMS in one place. Reddit users with experience of several systems recommend it for single-product or early-stage firms.⁸ One consultant said it “works great if you’re pretty early in your process.”⁹

It also covers software as a medical device: IEC 62304-aligned release management, Jira and GitHub sync, and SBOM scanning.⁶¹⁰ A 2026 vendor webinar shows the Jira and GitHub workflow.⁷ Some software-heavy teams on Reddit prefer dedicated tools.⁹

Look elsewhere if you:

• Are a very small team on a tight budget. Small teams report they couldn’t justify the cost.¹¹¹²
• Need pharma GMP features. Greenlight Guru is built only for devices.²
• Run complex manufacturing. Users report it gets cumbersome with several product lines and weak as a PLM for BOMs and change requests.⁹¹¹

Greenlight Guru pricing

Greenlight Guru publishes an entry price: “eQMS packages start at $12,000 per year” (checked September 2026).² The page doesn’t say how many users or modules that covers, and the vendor says you can start with some capabilities and add more later. Subscriptions are annual.²

What’s included and what’s extra:²

• Included: validation documentation for every release, a dedicated customer success manager, training resources and support.
• Extra: implementation, quoted separately; the vendor says most implementations take two to eight weeks. Paid add-ons (Guru Assist, Guru Guidance, professional services) cost more again.

What buyers actually pay is higher:

• Vendr reports a median of $43,989 a year, with deals from $20,975 to $54,739.¹³ Vendr doesn’t show team sizes or dates.
• A 40-person company on Reddit reported paying about $30,000 in its first year (January 2025).¹¹
• A current customer wrote in March 2026 that “the cost is starting to hurt a bit as the team grows.”¹⁴

Our working estimate for a 10-person team is $12,000 to $30,000 a year plus implementation. Greenlight Guru itself says it “may not be the lowest-priced option.”² One Reddit user suggests getting competing quotes and asking for a price match.¹⁴

Features

Greenlight Guru has no public help center for its QMS, so we checked features against its interactive product tour, recorded demos and release notes.¹⁵¹⁶

Document control and records

Documents are stored as files. The tour (captured in 2024) shows a document record with the uploaded file, a PDF viewer, “Download Editable” and “Upload New File” buttons, routing, training and file history.¹⁶ We found no native text editor. Instead, the vendor says you can create and co-author controlled documents in Google Docs and Microsoft Office for the web while Greenlight Guru handles versions and approvals.¹⁷¹⁸ Approvals use 21 CFR Part 11 signatures, and document changes can trigger training automatically.¹⁹ Quality-process task lists export to CSV.²⁰ There’s also a JSON REST API with bulk import.¹⁸

Design controls and risk

This is Greenlight Guru’s strongest area:

• Design controls: the tour shows a design control matrix linking user needs, inputs, outputs, verifications and validations, with Jira and GitHub references on the cards.¹⁶
• Risk: a risk matrix of hazards, foreseeable events, hazardous situations and harms.¹⁶
• Traceability: trace graphs flag missing links across design, risk and tests.²¹
• Exports: the vendor says you can generate trace matrices, the DHF and the risk file, though we found no documentation showing it.²¹

CAPA and quality events

CAPA, customer feedback (complaints), nonconformance and audit each have their own workspace. A June 2025 release added custom fields to all four.²⁰ Complaint handling includes a step for deciding whether regulatory reporting is needed, which creates a task to prepare the FDA report.²² We found no eMDR or EUDAMED submission, no documented post-market surveillance report workflow, and no UDI management.

Training

Training can be assigned by role or group and tracked by person, team or document.²¹⁶ Greenlight Guru AI can draft training quizzes.²

Supplier management and parts

Suppliers get risk levels. A policy matrix suggests the required documents, audits and monitoring, suppliers can be imported from CSV or Excel, and they link both ways to nonconformances, audits and complaints.²³ Items and multi-level BOMs have approval routing.¹⁶ There’s no documented device history record workflow, and users report this side is less mature than the design side.¹¹⁹

What users say

• G2: 4.5/5 from 431 reviews, with 8.6/10 for ease of use and 9.4/10 for quality of support (checked in a browser on September 29, 2026).²⁴
• Capterra: 4.4/5 from 82 reviews, with 4.2 for ease of use and 4.5 for customer service.¹²

Recurring themes:

• Easy to learn. Capterra reviewers call it “quick to learn and easy to use.”¹²
• Costs climb with headcount. Reviewers mention this on Capterra and repeatedly on Reddit, including current customers.¹²¹⁴¹¹
• Rigid as you grow. Consultants and former users report it working well early but becoming cumbersome with more data, product lines or manufacturing processes.⁹²⁵
• Support is mostly praised. Two medical device CEOs on Capterra described poor experiences.¹²

On Reddit, first-hand comments are split: 7 negative, 6 positive and several mixed, once vendor, competitor and hearsay posts are excluded. The positive ones come mostly from small, early-stage teams.⁸⁹¹¹

All 440 G2 reviews were read in October 2026: 88% are labelled by G2 as invited by the vendor or incentivized, and 58% of them arrived within a single six-week window in early 2024.²⁶ Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Security, hosting and validation

Greenlight Guru states it is certified to ISO 27001, ISO 42001, ISO 9001 and SOC 2. It doesn’t say whether the SOC 2 report is Type I or Type II.²²⁷ The platform runs on AWS.² According to its architecture overview, customer data stays in one region: the US, Germany, Singapore or Australia, as set in the order form.²⁸ That document dates from 2022, so EU buyers should confirm German hosting in writing.

Each release ships a Part 11-compliant installation qualification protocol and completed OQ and PQ reports, included in the subscription.² SSO, role-based access and Part 11 audit trails are listed as standard.²

Buying and contract terms

• Trial: we found no free trial or sandbox. The website has an interactive product tour and recorded demos, and a live demo goes through sales.²⁹¹⁹
• Contract: subscriptions are annual, though the order form sets the term: the customer agreement defaults to two years if none is stated. Order forms renew automatically unless either side gives 60 days’ notice.²³⁰
• Price increases: the agreement lets Greenlight Guru raise fees at each renewal with 90 days’ written notice, with no cap.³⁰ There’s no list-price history to compare yet, because the pricing page carried no prices until 2026.³¹ We found no first-hand user reports of renewal increases (October 2026).
• Leaving: Greenlight Guru says you can export quality records in standard formats without paying for services.² The API exports documents, design controls, suppliers, quality events and training records as JSON. Its documentation is for customers only.¹⁸
• If Greenlight Guru closes or is sold: after any termination or expiry you have 90 days to request an export of your data.³⁰ The agreement has no escrow and no clause specifically covering the vendor’s insolvency, the end of the service or a change of owner, and Greenlight Guru can change it without prior notice.³⁰
• Go-live: the vendor says standard implementations take two to eight weeks, and lists SOP templates in the package.²
• EU data: a public data processing agreement exists only for the clinical product.³² The subprocessor list is linked from the privacy policy but sits on a trust center page we couldn’t read without JavaScript.³³

Company and ownership

Greenlight Guru is the trading name of Soladoc, LLC, an Indiana limited liability company (register number 2013120200174) with its head office in Indianapolis.³⁴ The register lists it as active.³⁵

• Funding: a $1.25 million seed round from individual angel investors in 2015,³⁶ then more than $120 million from growth investor JMI Equity in June 2021.⁴ In June 2025 the company still described itself as backed by JMI Equity.³⁷
• Acquisitions: Vertex Intelligence, a data science firm (May 2022), SMART-TRIAL, a Danish EDC maker (June 2022), Ultralight Labs (June 2025) and Enzyme (July 2025).³⁸³⁹⁵
• Accounts: the US company publishes no financial statements, and we found no SEC filings.⁴⁰ Its Danish subsidiary, MEDEI ApS (also registered as SMART-TRIAL ApS, CVR 35139710), contracts for the clinical product outside the US.⁴¹

Verdict

Greenlight Guru scores 7.7. Its strengths are ISO 13485 and FDA coverage, linked design controls and risk, and a validation package with every release. Growing device teams heading for FDA clearance should shortlist it. Reasons to hesitate are cost (users report the bill rising with headcount, and implementation comes on top), no self-serve trial, and gaps around UDI, production records and regulatory reporting.

Visit the Greenlight Guru website (made by Greenlight Guru)