Moving MedTech Forward

Greenlight Guru Quality

Unlock efficiency with the leading cloud-based QMS software designed to improve speed and quality while lowering risk and cost.

1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

Greenlight Guru Quality

Rethink What Your QMS Can Do

Upgrade your paper-based or generic QMS to a modern, cloud-based solution that enables you to track quality events, trace design controls to risk, ensure compliance, and more.

Our QMS software helps you bring medical devices to market faster and keeps them on the market longer.

MedTech Quality Solutions

Built To Support Medical Device Companies

Your QMS software is optimized for the unique challenges and strict requirements of MedTech. Connect your people, processes, and data under one single source of truth.

Pre-validated per FDA & ISO best practices

Ensure compliance from the start without lifting a finger. Your software comes aligned with 21 CFR Part 820, ISO 14971:2019, ISO 13485:2016, and FDA requirements.

End-to-end traceability

Enhance team collaboration, break down information silos, and maintain a single source of truth. By reducing risk of noncompliance, your device can stay on the market longer.

Scaleable across your product lifecycle

Create a culture of quality from idea, to development, to post-market surveillance under one connected system.

Real-time audit readiness

Spend less time digging through spreadsheets and binders with every auditor request. With one interconnected, living database, you can get through audits with fewer issues in just a few clicks.

One Interconnected Quality Ecosystem

Unify your whole team under one easy-to-use quality management system.

Document Management

Your documents should increase efficiency, not slow you down. Seamlessly review, approve, update, and link documents all in the cloud. All with a click.

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Design Controls & DHF

The most advanced design controls functionality for MedTech. Intuitively integrate risk while you design, manage traceability, and maintain a living history file.

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Product Development

Connect your quality and product development teams to streamline collaboration, increase efficiency, and reduce risk across your product lifecycle.

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Quality Process Management

Give your team the tools they need to enable a culture of quality: compliant, yet flexible workflows for CAPAs, customer feedback, and audits.

Training Management

Your company's success and your team's skills go hand in hand. Create, manage, and track individual or role-based training conveniently inside your QMS.

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SOP Templates Get over 70 audit-tested and customizable templates. Streamline system set-up, ensure compliance, and follow industry best practices from the start.

Focus on the Work That Matters Most.

See how Greenlight Guru’s MedTech Suite can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.

$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

Greenlight Guru Quality

1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

Rethink What Your QMS Can Do

Built To Support Medical Device Companies

Your QMS software is optimized for the unique challenges and strict requirements of MedTech. Connect your people, processes, and data under one single source of truth.

One Interconnected Quality Ecosystem

Unify your whole team under one easy-to-use quality management system.

Focus on the Work That Matters Most.

$ 125 k

3

402