GREENLIGHT GURU EQMS PRICING

Built for medtech companies at every stage. Predictable and transparent from the start.

Greenlight Guru’s software and expert services are designed exclusively for medical device companies, from early stage to global scale. Whether you’re preparing for a first submission, managing quality across a commercial portfolio, building out your SDLC for SiMD or SaMD, or running a clinical study, our Gurus are there to guide you every step of the way.

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Greenlight Guru eQMS

Greenlight Guru eQMS keeps design, risk, documents, training, suppliers, and quality events connected and aligned to regulatory standards. Your team spends less time chasing approvals and rebuilding records, and has a stronger quality system when an auditor or customer asks to see it.

Aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304.

Greenlight Guru eQMS packages start at $12,000 per year.

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PLATFORM

Role-based security and SSO Give people the access they need while keeping a complete activity history and Part 11 audit trail.
Connected records Link documents, design, risk, suppliers, and quality events so the full history is easy to follow.
Integrations and API access Keep teams in the tools they already use without losing the controlled quality record.
Data exports Export your records when you need them, in formats you can use.

QUALITY MANAGEMENT

Document control Keep the current version in use, route approvals, and capture Part 11 electronic signatures without managing the process through email.
Change management Move changes through review and approval, then issue retraining automatically when the change is released.
Training management Assign training by role or group and see who is complete, overdue, or still needs to act.
QMS templates Start with audit-tested templates for your quality manual, management reviews, project and risk plans, supplier surveys, and quality event procedures.
Supplier management Qualify suppliers, set oversight by risk, manage approvals and audits, and monitor performance over time.
Compliance frameworks Connect the requirements you follow to the records that show the work was completed, so your team isn’t gathering the evidence from scratch.

PRODUCT DEVELOPMENT

Design controls Manage requirements, reviews, verification, validation, and the design and development file as the product takes shape.
Risk management Run ISO 14971 hazard analysis and FMEA, then link risk controls to requirements and verification.
Traceability See how a design change affects risk, testing, and quality records before a gap reaches a design review or submission.
Parts and inventory Manage part records, bills of material, receiving, incoming inspection, and stock.
Jira and GitHub integrations Let engineers work in Jira and GitHub without asking them to enter the same information again for Quality.

SOFTWARE DEVELOPMENT LIFECYCLE MANAGEMENT

Software releases Manage versioned software parts, release records, and approvals tied to change control.
Development evidence Bring test results, SBOMs, and vulnerability reports into Greenlight Guru without copying the data by hand.

POST-MARKET QUALITY EVENTS

Complaints, CAPAs, and nonconformances Configure each process and connect events to the products, design records, risks, suppliers, changes, and training they affect.
Audit management Keep audits, findings, actions, owners, and evidence together, so preparation doesn’t become a last-minute search.
Post-market trends See recurring complaints and quality events across products and processes while there’s still time to act.
Supplier monitoring Keep supplier performance, issues, audits, and approvals connected as your supplier base grows.

AI-DRIVEN WORKFLOWS

Greenlight Guru AI helps your team find information, understand context, and draft content faster. Search quality records in plain language, get answers based on those records, summarize change orders, and create training quizzes.

Customer data is not used to train AI models, and Greenlight Guru's AI management system is certified to ISO 42001.

EXPERT ONBOARDING AND IMPLEMENTATION

Standing up a quality system takes work no matter what solution you choose. Your procedures, documents, device, and team all have to be reflected in the system before it holds up in an audit.

When implementation is free, the burden of setting up your quality system falls entirely on your team. We quote implementation separately because we offer dedicated support at every step. You’ll have your own Medical Device Guru who will help you create an implementation plan based on your goals, milestones, and needs.

Together, your team and your Medical Device Guru will:

Plan the implementation
Configure Greenlight Guru around your processes
Migrate your documents
Start with medical device QMS templates
Train your team

GURU SERVICES

Guru Assist

Get in-app coaching and expedited software support.

Guru Guidance

Schedule time with a medical device expert who knows your goals and challenges.

Professional services

Get help with configuration, audit prep, design and risk reviews, and automations.

The leading compliance platform
for medtech

Work in a platform that's purpose-built to help you start fast, stay on track, and get your data as soon as it's ready, not weeks later.

Core features always included

Our goal is to help you reach your goals faster and with less risk, so you'll never have to upgrade to get core features like AI search, chat, and connected workflows.
Designed to grow with you

From early stage startups to global medical device leaders, Greenlight Guru grows with you so you never have to switch. Start with what you need today and add more as your team, products, and complexities grow.
Transparent and predictable pricing

Comparing compliance software is hard enough. Unpredictable or unclear pricing shouldn't make your job more difficult. We'll work with you to size the right subscription for your team today, and be clear about what changes as you grow, so you can plan ahead.

You get more than just software

Validation documentation

Greenlight Guru provides updated validation documentation with every product release at no additional cost. Your team completes a short installation qualification step instead of running a new validation project each time the software changes.

Dedicated customer success manager

You have a named contact to help your team get the most from Greenlight Guru, answer product questions, and adjust the system as your needs change.

Training and support

Your team has access to Greenlight Guru Academy, the Greenlight Guru community, the help center, and our support team.

Security and privacy

Every subscription includes role-based security, encryption, and the protections covered by our ISO 42001, ISO 27001, ISO 9001, and SOC 2 certifications.

Trusted by 1000+ medical device companies

"Greenlight Guru's software is expensive on day one, and dirt cheap on day two. This is a year's worth of someone's salary already done, implemented, and ready to go."

Daniel Powell, CEO, Spark Biomedical

Frequently asked questions

How much does Greenlight Guru cost?

Greenlight Guru quality management and product development subscriptions start at $12,000 per year. Greenlight Guru EDC subscriptions start at $9,000 per year. Your price depends on the products and capabilities you need.

Quality implementation and clinical study-build services are priced separately. We provide the subscription and services costs before you sign. Validation documentation, a dedicated customer success manager, training resources, and support are included with the subscription.

How does Greenlight Guru pricing compare with other medical device QMS options?

Greenlight Guru may not be the lowest-priced option. You are paying for software built exclusively for medical devices, validation documentation maintained with every release, and support from people with medical device quality and regulatory experience.

When comparing vendors, look at the full first-year cost. Ask what implementation, templates, validation, support, users, integrations, and product updates cost. Just as important, ask who will configure the system and how much of that work your team will need to do.

Does Greenlight Guru support post-market quality management?

Yes. Greenlight Guru supports post-market surveillance and post-market quality management for medical device companies, from single-product teams through multi-site manufacturers with high complaint volume. Teams use it to manage complaints, CAPAs, nonconformances, audits, suppliers, changes, training, and post-market trend analysis. Complaint, CAPA, design, and risk records stay linked, so post-market signals feed back into your risk file instead of living in a separate system.

How configurable is Greenlight Guru?

Unlike quality systems that lock you into one fixed workflow, Greenlight Guru is built to configure around your process, not the other way around. You can configure workflows, document types, fields, views, versioning, change order types, quality event stages, risk matrices, and supplier criteria, including different workflows for different product lines or business units. Your quality team can make these changes directly, without a developer or a paid services engagement. 
The controls you rely on for compliance, including audit trails, approvals, electronic signatures, and linked records, remain in place.

Is AI included with Greenlight Guru's quality management and product development software?

Yes. Greenlight Guru AI can help your team search quality records, answer questions based on those records, summarize change orders, draft training quizzes, and more. A person on your team reviews the output before using it.

Customer data is not used to train AI models, and Greenlight Guru's AI management system is certified to ISO 42001.

Does Greenlight Guru offer clinical study-build services?

Yes. Our clinical experts can design your eCRFs, build your study through user acceptance testing, and train sponsor, site, and CRO teams. We also offer supplier audit support and custom professional services. Each engagement is scoped to the study and priced separately.

Can I buy Greenlight Guru’s EDC without the quality management software?

Yes. Greenlight Guru’s EDC is a separate product. Sponsors and CROs can use it as their EDC without buying Greenlight Guru's quality management software.

Can I start with one clinical study?

Yes. You can start with a pilot or single study for a smaller upfront investment, then add studies, sites, and capabilities as your clinical program grows.

Can we change a live clinical study?

Yes. Your team can publish amendments and form changes without taking data capture offline or waiting for Greenlight Guru to release them. You control how each change is released to sites.

If we leave Greenlight Guru, what happens to our data?

Your data remains yours. You can export quality records and clinical study data in standard formats without purchasing a separate services engagement.

Do I have to buy every capability at once?

No. Start with what your team needs today and add capabilities later. Your account manager will confirm any change in price before it takes effect.

How long does eQMS implementation take?

Most standard implementation engagements take two to eight weeks. Your timeline depends on the processes, documents, configuration, and training included in your scope.

A named medical device consultant plans the implementation, configures the system with your team, migrates your documents, provides QMS templates, and trains your team. If you need work beyond the original scope, we will agree on the additional work, timing, and price before it begins.

Why is eQMS implementation priced separately?

Because implementation is hands-on work from a medical device consultant. Your consultant helps configure the system around your procedures, migrate documents, provide QMS templates, and train your team.

When comparing vendors, ask who does that work, what is included, how much your team must do, and what happens if the project needs more time.

What does the validation package include?

Greenlight Guru provides updated validation documentation with every product release. Each release includes a Part 11-compliant installation qualification protocol and completed operational and performance qualification reports. Software updates and the validation package are included with the subscription at no additional cost.

How is Greenlight Guru deployed, and how is customer data protected?

Greenlight Guru is cloud-based and accessed through a web browser, with nothing for your team to host. The software runs on Amazon Web Services and uses role-based security and encryption. Greenlight Guru is certified to ISO 27001, ISO 42001, ISO 9001, and SOC 2. A detailed security and data-storage overview is available from our team.

Can we use Greenlight Guru if we already work with a QA/RA consultant?

Yes. Your consultant can work in Greenlight Guru with your team during and after implementation. If you need a consultant, we can introduce you to one through our partner network.

Does Greenlight Guru support companies and markets outside the United States?

Yes. Greenlight Guru works with medical device companies across five continents. Our quality management and product development software supports international quality standards, and Greenlight Guru’s EDC supports more than 40 languages and EU MDR-aligned post-market studies. Talk with our team about the countries and regulatory requirements relevant to your device.

What is the contract length?

eQMS and product development subscriptions are annual. EDC subscriptions have a 12-month minimum, with the option to contract for the full length of a study.

Let's find the right fit

Tell us where your team is today and what you are working toward. We will show you the quality management, product development, or EDC capabilities that make sense and give you the full cost.

QMSR is here! Is your quality system ready?