Greenlight Guru for R&D Professionals

It’s time to focus more on doing value-added engineering work and less on busy work. With Greenlight Guru, you’ll be able to simplify your MedTech product development so you can do more of what you love.

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Streamline Product Development Throughout The Entire Product Lifecycle

Greenlight Guru’s single, centralized platform provides end-to-end traceability so you can drive accountability and meet deadlines like never before. This enables you to demonstrate a risk-based approach to development whether you are in early phases of design or already commercialized.

Why R&D Professionals Love Greenlight Guru

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

Built for Customers Like You

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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare

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Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical

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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare

https://blog.greenlight.guru/hubfs/Puzzle_Med-875x530-1.jpg

Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical

Simplify MedTech Product Development

Do more value-added engineering work and less compliance paperwork. Explore how our product development solution mitigates risk, accelerates timelines, and streamline processes.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

Explore Resources for R&D Professionals

Product Development

The Role of dFMEA in Risk Management for Medical Devices

Episode 325

Product Development

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

Free webinar for medical device professionals to gain the knowledge and strategies necessary to successfully implement IEC 62304 to ensure compliance, while developing superior ...

Product Development

2023 Risk Management True Quality Summit Series

With nearly every medical device regulatory agency placing risk management front and center it’s increasingly important understand what the regulations are asking for and which ...

Product Development

ISO 14971:2019 Gap Analysis Tool

Product Development

How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device

This free webinar provides a "how to" for DHF/TF and RMF creation for both SaMD and hardware devices.

Product Development

Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design

In this free, in-depth webinar, Satyajit ‘Sat' Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and ...

Product Development

Packaging Validation Best Practices

Episode 279

Product Development

Digitizing your SaMD Testing

Episode 274

Product Development

Usability Testing: Why can’t we get it right?

This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will use actual devices as case studies to take a critical look at the way we do ...

Product Development

Considerations for Building Your Own Cloud Device: Regulations, Privacy & Cybersecurity

Register for this free webinar presented by Abbas Dhilawala, CTO of Galen Data, who will describe these challenges and provide considerations that are critical for success.

Product Development

Supplier Quality Management: What MedTech Manufacturers Need to Know

By Nick Tippmann, Med-Tech Innovation

Product Development

Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device

A free, in-depth webinar covering integrating cloud and other modern computing technologies into the operation of medical devices and what cloud computing can teach us about the ...

Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

A comprehensive guide to software as a medical device (SaMD) packed with insights into how these products are regulated and what manufacturers should expect when building one.

Product Development

Early Feasibility Studies in Latin America

Episode 266

Product Development

Approaching Cybersecurity & Usability as a SaMD Company

Episode 264

Product Development

The Future of Lateral Flow Test Technology

Episode 263

Product Development

Bringing Medical Devices Into The Home

Episode 261

Product Development

The Future of Cybersecurity

Episode 257

Product Development

Achieving Operational Readiness through Good Project Management

Episode 256

Product Development

Bridging the Gap Between Development and Regulatory Teams

A free, in-depth webinar covering the intersection and friction between development and regulatory teams, with a focus on remedies in the form of processes, tools and approaches, ...

Product Development

How to Proactively Predict & Mitigate Risk throughout the Supply Chain

A free, in-depth webinar covering proactive strategies for predictive risk mitigation throughout the supply chain based on core principles of Risk Based Methodologies as it ...

Product Development

Top Things You Should Know When Developing Software as a Medical Device (SaMD)

A free, in-depth webinar presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to ...

Product Development

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

Episode 251

Product Development

Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability

A free, in-depth webinar exploring a more efficient process to control and collaborate on product development to streamline work for faster submissions and continuous improvement.

Product Development

How To Select A Contract Manufacturer

Episode 245

Product Development

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Episode 236

Product Development

Project Management for Product Development of Medical Devices

Episode 233

Product Development

Checklist For Selecting Suppliers + Contract Manufacturers

Product Development

5 Key Points to Consider in Design Transfer of Medtech

Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at Cirtronics, ...

Product Development

Approved Supplier List Form Template

Product Development

Navigating the MedTech Cybersecurity Ecosystem

Episode 219

Product Development

Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?

Free interactive webinar exploring combination products and what manufacturers need to know about their unique value proposition in the market, complex regulatory requirements, ...

Product Development

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200

Product Development

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Episode 198

Product Development

How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for ...

Product Development

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Episode 191

Product Development

Prioritizing Medical Device Reimbursement During Product Development

Episode 178

Product Development

How to Use UX to Streamline Medical Device Product Cycles

A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle ...

Product Development

Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.

Product Development

Why Supplier Quality Management Is So Important

Episode 126

Product Development

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

Product Development

Content Toolkit for Medical Device Product Developers

Product Development

Ultimate Guide To Agile Design And Development For Medical Devices

In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.

Product Development

Bill of Materials

Product Development

Importance of Software Requirements in Product Development

Episode 111

Product Development

Predicate Device

Product Development

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer, Quality Digest

Product Development

Product Requirements Guide + Checklist with Writing Tips

Product Development

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

Product Development

Wearable Medical Devices

Product Development

Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

Product Development

New Product Introduction Process (NPI)

Product Development

Why User Needs Matter & Their Benefits in Streamlining Device Design and Development

A free webinar about connecting empathy and purpose to gain meaningful user insights that translate into optimal design inputs and product quality in medical device development.

Product Development

Medical Device Product Development Value Proposition

Episode 92

Product Development

Labeling Medical Devices

Product Development

Electronic Batch Records

Product Development

5 Practical R&D Tips for Medical Device Developers

Product Development

Checklist for Selecting Suppliers to Your Medical Device Company

Product Development

Medical Device Product Development Checklist

Product Development

21 CFR Part 11 compliance checklist for clinical records and e-signatures

Here are our pointers on what you should be aware of if you're looking to achieve compliance with FDA's 21 CFR Part 11, particularly when collecting or maintaining clinical data.

Product Development

How to Conquer Supplier Management for Medical Device Companies

Free webinar presented by Kyle Rose of Rook Quality Systems and Greenlight Guru. Learn to conquer supplier management by updating your processes and using best practices to comply ...

Product Development

Medical device product development: pitfalls you need to avoid

By John Speer, MassDevice

Product Development

Medical device product development: 7 pitfalls you need to avoid

By Jon Speer, Medical Design & Outsourcing

Product Development

How Software Can Be Leveraged to Streamline Device Development

Product Development

Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54

Product Development

Medical Device Project Management Best Practices

Product Development

Navigating the difficult road of medical device product development while avoiding the common pitfalls

By Jon Speer, MedCity News