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Medical Device Product Development

Intelligent tools for medical device design and development

Build high-quality devices faster with Greenlight Guru’s AI-powered solutions designed specifically for medtech product development.

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Trusted by 1000+ medical device companies

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Compliant product development without slowing down your team

 
 
"We needed a better way to manage risks and requirements, something compliant, user-friendly, and fast to adopt. Greenlight Guru exceeded expectations, simplifying collaboration and accelerating our engineering work."

Generic eQMS tools weren’t built for medical device development

41% of teams say the toughest part of product development is documenting new work during design controls. Greenlight Guru’s medtech-specific eQMS solutions simplify documentation and accelerate development.

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Confidently accelerate development

Start quickly and never slow down with integrations for the dev tools you’re already using.

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Customize your path to compliance

Configure your eQMS to meet your current workflows, without worrying about noncompliance.

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Maintain clarity as teams and products evolve

Keep requirements, validation, and risk easy to work with as products mature, teams grow, or ownership changes.

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Bridge the gap between development and compliance

Most product development tools make Quality an afterthought. With Greenlight Guru, compliance documentation builds in the background to keep Product and Quality in sync.

Build your DHF as you build your product
Capturing requirements is just the start. Greenlight Guru links design inputs, risks, and tests, so traceability builds automatically.

Link as you work
Add requirements, connect risks, and flag verifications without leaving the workspace or interrupting your team’s flow.

Flag traceability gaps before they become blockers
AI checks your requirements for verifiability, while real-time trace graphs expose missing links across design, risk, and test.

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Bridge the gap between development and compliance

Most product development tools make Quality an afterthought. With Greenlight Guru, compliance documentation builds in the background to keep Product and Quality in sync.

Made for modern medical device development

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Developer integrations

Integrations with tools like Github and Jira provide effortless traceability without changing how your team works.

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Engineer-friendly design

Every screen and workflow is designed with speed, clarity, and usability in mind, so your team will actually want to use it.

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Designed for software-enabled devices

Built for the fast, iterative cycles of SaMD and SiMD teams. Includes SDLC support and automation that fits how you ship software.

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Built-in intelligence

AI features help reveal gaps, suggest connections, and reduce manual work while always keeping humans in the loop.

Explore the Greenlight Guru Platform

Built by medtech experts and ready for the entire product lifecycle. Whatever stage your device is at, our solutions help you move faster, stay compliant, and bring safe, high-quality devices to market.
Quality management made simple

An AI-powered eQMS built just for medtech and aligned with industry standards. 

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All your clinical data,
all in one place

Build studies, collect clinical data, and manage it all in one easy-to-use system.

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Support from
medtech experts

Get personalized onboarding and on-demand assistance from our legendary Gurus.

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Designed in accordance with:

iso 13485 iso 11137 iso 11607
iso 14971 iso 11135 iso 17665 iso 10993
iec 60601 iec 62304 ista-3a
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Build smarter. Stay compliant

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