Greenlight Guru

Medical device quality management software with CAPA, design controls, and risk files.

Pricing: subscription, custom
Open source: No

Editorial review

Greenlight Guru has not yet been editorially reviewed. User reviews and published field data below are unaffected — we say so rather than implying an editorial verdict.

Facts & attributes

Every value carries its evidence state. “—” means unknown — never a silent default (P-02).

Identity · Taxonomy

Tags(open-source;cloud-native): eQMS, medical devices, CAPA, clinical trials, design controlsVerified

Platform · Deployment

Delivery model(SaaS;self-hosted;desktop;mobile;embedded;managed-cloud;appliance): SaaSVerification pending

Pricing · Licensing

Pricing model(free;subscription;usage;seat;asset;transaction;revenue-share;perpetual;custom): subscription, customVerified
Starting price(29): 1000Verified

Features · Product · Fit

Core capabilities(authoring;automation;analytics): document control with Part 11 e-signatures, change and training management, CAPA, audit, and nonconformance tracking, supplier management, design controls and ISO 14971 risk management, clinical data capture (EDC)Verification pending

Api · Integrations · Ecosystem

API available(true/false): trueVerification pending

Security · Privacy · Compliance

Regulatory compliance(HIPAA;PCI DSS;FedRAMP;GDPR support): ISO 13485, FDA QMSR, ISO 14971, IEC 62304, FDA 21 CFR Part 11Verification pending
Security certifications(SOC 2 Type II;ISO 27001): ISO 27001, ISO 42001, ISO 9001, SOC 2Verified

Support · Docs · Services

Support channels(email;ticket;chat;phone;community): expert Guru support, partner network consultants, webinars and trainingVerification pending

Audience · Use · Case

Best for(Neutral editorial summary): Medical device companies of every stage needing audit-ready eQMS, design controls, and clinical evidence managementVerification pending
Company-size fit(individual;SMB;mid-market;enterprise): SMB, mid-market, enterpriseVerification pending
Primary use cases(build;monitor;automate): medical device quality management, regulatory submissions, postmarket quality management, clinical trialsVerification pending

Vendor · Maintainer

Vendor type(commercial;foundation;community;government;consortium;individual): commercialVerification pending

Also categorized in

Nonconformance Management Tools Medical Device Quality Systems

User reviews

Review policy

No published reviews yet.