Greenlight Guru targets medical-device quality and product teams. It combines controlled quality records with design and risk traceability; developer integrations can connect engineering evidence. Clinical data collection is a separate offering, so a buyer should define the quality, development and study scope before comparing proposals.
Built from vendor sources checked ; AI-assisted drafting. Documentation review, not a hands-on test. How pages are made
Medical-device companies needing quality-event and design evidence linked across product development and post-market work. Software designed for medtech does not make a customer's QMS, device, submission or study compliant. The customer remains responsible for procedures, intended-use validation, data integrity, risk decisions, regulatory submissions and human approval of AI suggestions. Distinguish Quality, Product Development and Clinical entitlements; validate customer-built integrations; verify current certificates and data terms; and do not assume offline operation from browser access or exports.
Worth evaluating when linking medical-device design and quality evidence replaces repeated reconciliation between teams. Compare the quoted scope with your development stage and post-market obligations. A generic checklist need alone is not a strong reason to buy a medtech platform.
Trial or demo on request. Sources checked .
Vendor visuals—not a QHSEtech hands-on test.
Greenlight Guru is a medtech platform with distinct Quality and eQMS, Product Development and Clinical or EDC product areas plus AI, API and expert-service capabilities. Clinical can be purchased separately; its study limits, add-ons and pricing must not be inferred from an eQMS or product-development subscription.
| Capability | Evidence | Scope and source |
|---|---|---|
| Controlled documents and change | Documented by vendor | The eQMS supports versioned documents, configurable review and approval, Part 11 electronic signatures, audit history, change orders and downstream retraining. Buyers must map configured workflows to approved SOPs and permissions. Controlled document workflowsCurrent pricing, package scope and separately priced services |
| Training assignment and evidence | Documented by vendor | Training can be assigned by role or group, triggered by document changes and tracked as complete, overdue or pending. Demonstrate trainer sign-off, retraining rules, exception handling and exportable evidence. eQMS workflows and connected quality scopeCurrent pricing, package scope and separately priced services |
| CAPA, nonconformance and complaint workflows | Documented by vendor | Configurable quality-event processes can link investigations, tasks and evidence to products, risks, suppliers, documents, changes and training. Configuration does not replace the buyer's investigation, root-cause and effectiveness-check procedures. eQMS workflows and connected quality scopeCurrent pricing, package scope and separately priced services |
| Audit planning and findings | Documented by vendor | Internal and supplier audits can be scheduled with reminders, findings, actions, owners, evidence, approvals and links to CAPA or documents. Test recurring schedules, overdue escalation and closure evidence. Audit planning, findings and traceability |
| Supplier qualification and monitoring | Documented by vendor | Supplier records support buyer-defined risk classification, policy-matrix prompts, supporting documents, reminders and links to audits and quality events. Risk levels are not prebuilt; the customer must define and govern them. Supplier qualification and risk controls |
| Design controls and DHF traceability | Documented by vendor | Product Development links user needs, inputs, outputs, verification, validation and design reviews and can generate traceability and DHF-related exports. Confirm the subscribed development scope and required review gates. Design controls and development traceability |
| Risk management and risk matrices | Documented by vendor | The risk workspace supports configurable acceptability matrices, hazards and links from risk controls to design controls, documents and verification evidence. Standards alignment does not approve the buyer's risk criteria or conclusions. Risk-management workspaceDesign controls and development traceability |
| Parts and multi-level BOM management | Depends on scope | Product records can include families, items, multi-level BOMs, suppliers and lifecycle changes. Confirm entitlement, revision behavior, inventory and incoming-inspection depth, and any ERP or PLM source-of-truth boundary. Parts and multi-level BOM managementCurrent pricing, package scope and separately priced services |
| Engineering and software-release evidence | Depends on scope | Jira and GitHub integrations and software-release records can connect engineering issues, tests, SBOMs or vulnerability evidence to controlled records. Validate exact objects, direction, cadence, permissions, failure handling and subscription entitlement. Design controls and development traceabilityCurrent pricing, package scope and separately priced servicesREST API and integration responsibilities |
| REST API and event integration | Depends on scope | The REST API uses JSON and can expose import, export, update or event actions, but coverage varies by solution and endpoint. Customer-built middleware is built, maintained and validated by the customer or its partner; API activity is described as entering the audit trail. REST API and integration responsibilities |
| AI search, summaries, chat and training assistance | Depends on scope | AI capabilities include search, QMS-grounded answers, summaries, training analytics or quiz drafting, and an MCP-based AI connector. Outputs are suggestions requiring human review; confirm licensed functions, approved models, source linking, retention and external-assistant governance. AI functions, human review and data-use boundaryREST API and integration responsibilitiesCurrent pricing, package scope and separately priced services |
| Clinical electronic data capture | Depends on scope | Greenlight Guru Clinical is a separate EDC product for study setup and clinical data capture. It can be purchased without Quality; do not infer EDC functions, validation or study entitlements from an eQMS quote. Clinical EDC scopeClinical package limits and add-onsCurrent pricing, package scope and separately priced services |
3 additional areas. Status describes reviewed sources, not hands-on performance.
Also watch for: Published starting amount lacks an explicit currency code in the reviewed page. Clinical scope should not be assumed included in an eQMS package.
Annual subscription with published dollar-denominated starting amounts and separately priced services
The official pricing page states that Quality and Product Development subscriptions start at $12,000 per year and EDC subscriptions start at $9,000 per year. The page does not display an ISO currency code, so confirm currency. Quality implementation and clinical study-build services are priced separately. Ask the quote to identify users, products, capabilities, API and integrations, AI, migration volume, clinical studies, sites, storage, add-ons, support, renewal and data-exit terms.
Pricing sources checked : Selected sources checked; plan prices above.
Greenlight Guru describes a cloud service accessed through standard web browsers. Exports are not equivalent to supported offline editing; require a written workflow and demo if disconnected operation is essential.
Do not assume so. Clinical is a distinct EDC product and can be bought without Quality. Its tiers set study and site limits, and some functions are tier-dependent or add-ons.
No. It provides controlled records and workflows designed for medtech standards, but the customer owns procedures, configuration, training, risk decisions, validation, record accuracy and regulatory conclusions.
It can reduce evidence-generation effort for the underlying release, but it does not replace the customer's assessment of intended use, configuration, permissions, migrated data, integrations and regulated workflows.
The vendor documents Jira and GitHub integrations and a REST API. Exact objects and actions vary. A customer-built integration remains the customer's software to build, monitor, maintain and validate.
No. The vendor explicitly frames AI output as a suggestion owned and reviewed by a person. Require source references, approval controls, retention rules and a procedure for inaccuracies before regulated use.
The supplier page says risk levels are not prebuilt. The customer defines risk, supplier type and policy rules, so the demo should test those rules against the approved supplier procedure.
Request current ISO certificates, SOC 2 report and scope, penetration-test summary, subprocessors, hosting and data-location details, encryption and key controls, recovery evidence, incident terms, retention and deletion, and the executed SLA.
Drawn from the profiles behind the Alternatives list above: most category tags shared with Greenlight Guru first, then the closest overlap in documented capability names, then A to Z. Ratings, search demand and sponsorship are not used; rows are shown A to Z.
Shared category tags: 5 (Quality Management, Document Management, others).
Differs: trial free trial documented (this profile: on request).
Same: scope, offline and price.
Shared category tags: 5 (Quality Management, Document Management, others).
Differs: offline partial workflow (this profile: unclassified).
Same: scope, price and trial.
Shared category tags: 5 (Quality Management, Document Management, others).
Same: scope, offline, price and trial.
Also recorded as Greenlight Guru eQMS. Older entries under a previous name may describe a different release or owner.
Star ratings and review counts from the old catalog are not shown: no source for them was recorded.
