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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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GREENLIGHT GURU

The End-to-End Platform Built for MedTech Lifecycle Excellence

 
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1,000+ of the world’s leading MedTech companies trust Greenlight Guru.

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Close the Gaps

Controlling critical data and documenting processes can quickly get lost in the weeds at high-growth MedTech companies. What no one tells you is how gaps in these activities impact your commercialization journey. Add in regulatory and compliance requirements to your development goals, and it only gets more challenging. Just a QMS isn’t enough anymore. Your teams need more.

Your MedTech Lifecycle Excellence Platform

Greenlight Guru is more than your generic QMS software provider. We give you what you need – consistency and flexibility with a seamless, compliant
source of truth.

Document Management
Change Management
Risk Management
Multi-level Design Controls
Product Management
Quality Process Management
Training Management
AI/ML Advantages
Document Management Change Management Risk Management Multi-Level Design Controls Product Management Quality Process Management Training Management ML Advantanges-01
Document Management
Document Management

Leverage our secure, cloud-based document management system to give your team the tools they need to succeed. Review & approve with Part 11 compliant e-signatures. Experience flexible review & approval workflows with full document revision control. Discover what’s possible with real traceability.

Explore Document Management

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Change Management
Change Management

Conducting changes within compliance shouldn't be a worry. Leave fretting over how to manage change control processes in the past. No matter how big the change, discover our easy-to-use, formalized change control solution that is efficient, consistent, and intelligent. Adopt formal workflows to manage, analyze, and predict change impact and revisions.

Discover Modern Change Management

Risk Management
Risk Management

Experience integrated risk management, aligned with ISO 14971:2019. Greenlight Guru reduces the stress of audits and inspections by integrating risk-based thinking into your entire quality ecosystem.

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Multi-Level Design Controls
Multi-level Design Controls

The new era of design control is here. Move forward with multi-level design control software that keeps innovation, quality, and traceability at the forefront. Drive collaboration for design actions, link documents, conduct project reviews, and generate a design history file — all with a single click.

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Product Management
Product Management

Experience the only product management software built for MedTech. Build and manage items and multi-level BOMs as you design your medical devices. Create a seamless flow from DHF to product development processes, managing critical components of your device master record (DMR) while meeting ISO 13485 requirements.

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Quality Process Management
Quality Process Management

The only Quality Management Software designed to help MedTech teams deliver innovations to market, streamline compliance, and focus on quality — all in one end-to-end platform. Easily access up to date documents, maintain device traceability, mitigate risk, and build your bill of materials. Get automated quality workflows including Audit, CAPA, Nonconformance, and Complaints management.

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Training Management
Training Management

Eliminate the disconnect between documentation and people. Manage training with auto-generated records at the individual and document level. Ensure compliance and competency within your organization. Track training and obtain sign-offs — all in a single cloud-based solution.

Improve Training Management

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AI/ML Advantages

React. Predict. See how AI and ML can transform your document and change management processes. Experience visual traceability paired with AI-powered change impact analysis. Proactively evaluate quality performance and predict issues before they happen.

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Key Solution Features

While our end-to-end system covers a wide range of your business’ needs, we’ve identified five key areas that often overwhelm medical technology companies.

Quality Management

Consistently impress auditors and investors with an unbeatable QMS. Where there are data or process gaps, Greenlight Guru’s QMS fills them for you.

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Product Development

Successfully collaborate and execute on product development with our integrated design control and risk solution. From research and design to launch and postmarket surveillance, we're here to enable the success of your medical device development every step of the way.

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Clinical

Get continuous clinical evaluation and trial data management to simplify compliance and reduce costs.

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End-to-end Support Throughout the MedTech Lifecycle

Discover how our industry-dedicated platform accelerates the delivery of life-changing medical devices to all of humanity throughout your product’s lifecycle.

Identify

Have the ability to identify unique problems and unmet needs of patients with software that enables collaboration and outcome-driven thinking.
Plan

Establish initial QMS procedures with software that makes managing training, documents, processes, instructions, and internal audits easier than you ever thought possible.
Design

Streamline product development with design control and product development software that keeps innovation, quality, and traceability at the forefront.
Submit

Move forward to regulatory submission with confidence by leveraging a platform that goes beyond baseline compliance requirements.
Deliver

Support validation, verification, and design transfer as you break into the market. Launch, manufacture, and distribute life-changing medical technology.
Monitor

Control the efficacy of your product with postmarket surveillance software that unlocks full traceability of quality events, including nonconformances, customer feedback/complaints, and CAPAs.
Improve

Excellence requires iteration. Improve the quality of life through your product by consistently meeting user needs. Learn industry best practices and unlock continuous improvement.

Are You Ready to Experience the Greenlight Guru Difference?

With solutions to improve every stage of your product lifecycle and a team excited to support you, achieving MedTech Lifecycle Excellence has never been easier.

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1000 +

trusted by medical device companies

1700 +

510(k) clearances and CE markings

2000 +

ISO 13485 certifications

1000 +

other approvals and audits passed

More Than Software to Fill the Gaps

Even with great software, MedTech companies fail every day. Succeed with Guru Edge. Whether you’re looking for advice from like-minded professionals or researching the latest MedTech trends, we have you covered with comprehensive, industry-specific services, tools, and education.

Academy

Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry practices. You’ll be equipped to build key competencies for your teams.

 Elevate Your Education
Community

We’ve created a network of your peers for inspiration and shared experiences. Connect to others and accelerate your path to success, no matter where you are in the product lifecycle journey.

 Find Your Community
Partner Ecosystem

We’ve built a partner network of hundreds of consulting firms in quality, regulatory, testing, design, and clinical so you can get the right help for your business needs.

 Learn More About Partners
Resources

Our Content Hub contains a wealth of resources for your team–from all things Greenlight Guru to MedTech knowledge and process problem solving, we have curated resources that will help you improve the quality of life for your patients.

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Dedicated Customer Success

We go beyond software support. We’re here to help you achieve workflow efficiencies, increase team collaboration, maintain compliance, and get your product to market quickly and safely. Your outcomes shape our outcomes – when you succeed, so do we.

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