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.

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

1,000+ 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

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

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.

$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

Greenlight Guru QMS

Featured Capabilities:

SMART-TRIAL by Greenlight Guru

Featured Capabilities:

Greenlight Guru Academy

Greenlight Guru for R&D Professionals

Streamline Product Development Throughout The Entire Product Lifecycle

Why R&D Professionals Love Greenlight Guru

Extend your resources by reducing manual errors

Deliver Safer Products Faster

Gain new visibility and mitigate risk

Automatically maintain full traceability

Leverage educational content from product development experts

Extend your resources by reducing manual errors

Deliver Safer Products Faster

Gain new visibility and mitigate risk

Automatically maintain full traceability

Leverage educational content from product development experts

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

Built for Customers Like You

Simplify MedTech Product Development

$ 125 k

3

402

Explore Resources for R&D Professionals

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

Packaging Validation Best Practices

Digitizing your SaMD Testing

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

Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)

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

Supplier quality management: What medtech manufacturers need to know

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

Ultimate Guide to Software as a Medical Device (SaMD)

Early Feasibility Studies in Latin America

Approaching Cybersecurity & Usability as a SaMD Company

The Future of Lateral Flow Test Technology

Bringing Medical Devices Into The Home

The Future of Cybersecurity

Achieving Operational Readiness through Good Project Management

Bridging the Gap Between Development and Regulatory Teams

How to Proactively Predict & Mitigate Risk throughout the Supply Chain

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

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

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

How To Select A Contract Manufacturer

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

Project Management for Product Development of Medical Devices

Checklist For Selecting Suppliers + Contract Manufacturers

5 Key Points to Consider in Design Transfer of Medtech

Approved Supplier List Form Template

Navigating the MedTech Cybersecurity Ecosystem

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

Waterfall vs. Agile: Battle of the Product Development Methodologies

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

How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Prioritizing Medical Device Reimbursement During Product Development

How to Use UX to Streamline Medical Device Product Cycles

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

Why Supplier Quality Management Is So Important

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Content Toolkit for Medical Device Product Developers

Ultimate Guide To Agile Design And Development For Medical Devices

Bill of Materials

Importance of Software Requirements in Product Development

Predicate Device

Qualifying Your Suppliers Using a Risk-Based Approach

Wearable Medical Devices

Biocompatibility Nuances and its Impact on Medical Devices

New Product Introduction Process (NPI)

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

Medical Device Product Development Value Proposition

Labeling Medical Devices

Electronic Batch Records

5 Practical R&D Tips for Medical Device Developers

Checklist for Selecting Suppliers to Your Medical Device Company

Medical Device Product Development Checklist

Budgeting for MedTech Clinical Activities Checklist

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

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Greenlight Guru