What tools reduce manual effort in medical device development?

Greenlight Guru streamlines product development by eliminating the need for spreadsheets and disconnected tools. Automated workflows, built-in templates, and centralized data help teams work faster and with fewer errors, so they can focus on building safer, more effective devices.

Can I build and manage multi-level BOMs while tracking design history automatically?

Yes. Greenlight Guru allows you to organize complex product structures with multi-level bills of materials while your design history file is updated automatically in the background, ensuring nothing gets missed as your device evolves.

Does Greenlight Guru provide end‑to‑end traceability from risk to design and quality activities?

With Greenlight Guru, every element of your product development is connected. You can trace the full lifecycle of a requirement, from user need to design input, design output, verification, and validation, along with associated risk management and quality records—without manual tracking.

How does Greenlight Guru support FDA and ISO requirements during product development?

Greenlight Guru is designed to help you meet regulatory expectations from day one. The platform supports structured documentation, controlled design processes, and validated workflows that align with 21 CFR Part 820 and ISO 13485 standards.

What sets Greenlight Guru apart from other platforms?

Unlike generic project or document tools, Greenlight Guru is built exclusively for the medtech industry. It brings product, quality, and regulatory teams into one purpose-built system that shortens development cycles, reduces risk, and supports global compliance from concept to launch.

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.

Trusted by 1000+ medical device companies

"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."

Eleanor Disney, Senior Systems & Clinical Engineer, Vexev

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.

Confidently accelerate development

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

Customize your path to compliance

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

Maintain clarity as teams and products evolve

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

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.

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

Developer integrations

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

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.

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.

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

Frequently asked questions

What is medical device product development software?

Unlike general-purpose project management tools, medical device product development software is designed with the unique needs of the medtech industry in mind. That means it’s built to manage the highly regulated design and development of medical devices, ensuring that all your engineering activities are documented in compliance according to applicable industry regulations and standards.

How does Greenlight Guru support FDA design controls and ISO 13485 design & development?

Greenlight Guru’s product development software is designed in accordance with ISO 13485:2016, as well as the FDA’s Quality Management System Regulation (QMSR). It provides compliant workflows for each phase of design controls, ensuring a compliant path from development to submission and post-market surveillance.

How do we build and maintain a Design History File (DHF) as we work?

With Greenlight Guru, your DHF builds automatically as your begin design controls, maintaining complete traceability throughout the system. Every element is versioned, reviewable, and export-ready.

What design artifacts can we manage?

Greenlight Guru allows you to manage every step of design controls, from user needs, design inputs, and design outputs, to verification and validation. You’ll also be able to carry out design reviews and link any element within the system.  

How does the platform connect risk management to requirements and verification evidence?

Greenlight Guru helps companies integrate risk throughout their product lifecycle with a system that allows them to build risk matrices, relate design controls and documents as risk control measures, and maintain a dynamic, audit-ready Risk Management File (RMF) at all times. Greenlight Guru’s software is built in accordance with ISO 14971:2019, the international standard for risk management for medical devices.

Does Greenlight Guru support software-enabled devices / SaMD workflows and modern engineering teams?

Yes, Greenlight Guru’s product development software is built for modern teams working on SaMD, SiMD, and traditional hardware devices. Greenlight Guru integrates with engineering tools like Github and Jira and is designed for the fast, iterative, cycles of software teams.  

What reports/exports can we generate for audits and submissions?

Greenlight Guru allows users to generate traceability matrices, a complete Design History File, and Risk Management File. Users can also download a Medical Device File (MDF), DDF, and audit trails.

What integrations are available for engineering workflows (e.g., issue tracking/dev tools)?

Greenlight Guru integrates with both Jira and Github, and includes an extensive suite of flexible APIs.

How do we migrate from spreadsheets and implement quickly without slowing R&D?

Greenlight Guru’s dedicated Onboarding and Implementation team will work with your team to devise a custom implementation plan, allowing you to migrate data and documentation in phases while your team can begin working in the system immediately.

Build smarter. Stay compliant

Design and develop medical devices with the structure and traceability regulators expect, without slowing your team down.

Additional resources

Blog

From Software Release Bottlenecks to Automated Velocity: SafeBeat’s Journey with Ultralight

Learn More

QMSR is coming. Is your quality system ready?

Medical Device Product Development

Intelligent tools for medical device design and development

Trusted by 1000+ medical device companies

Compliant product development without slowing down your team