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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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QMS for SaMD

Bring Your Software Innovation
to Life

Software as a Medical Device (SaMD) is one of the fastest-growing segments of the medical device industry, creating a new future of patient experience and care. But with rapid advancements and constant innovation, the SaMD landscape is changing quickly. Let us be your guide in delivering new innovations to patients.

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Training

Software Supporting Software

In addition to keeping up with a constantly evolving regulatory landscape, SaMD manufacturers must also effectively and efficiently optimize their software development practices to meet QMS requirements. But due to the speed of changes, there are often gaps in knowledge about global regulatory practices. Today's digital age demands a purpose-built solution for SaMD companies that performs better than disconnected general-purpose tools.

You’re in Good Company

Join some of the most exciting and innovative thinkers in the MedTech industry.

Built for Emerging Medical Technologies Like Yours

Pull together the power of your teams with our end-to-end solution to manage product development, quality, and suppliers. Watch your devices come to life and have confidence in the work you’ve invested in them.

Software Lifecycle
Jira Integration
Regulatory Compliance
Reduce Cybersecurity Risk
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Innovate. Iterate. Develop. Repeat.

Support an agile product development approach and enable your team to work dynamically and efficiently throughout the process by leveraging a platform that promotes transparency and cooperation rather than operating within disconnected silos. Instill risk-based processes to be carried out throughout the entire medical device software lifecycle and ensure compliance with IEC 62304.
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Connect Design to Development

Enable software development teams to leverage the agile functionality of JIRA when building software applications or components.

  • Give your team the freedom to execute work in JIRA.
  • Navigate seamlessly between linked design controls and associated JIRA issues. 
  • Achieve visibility between your design control and risk management system of record and the software implementation being tracked in JIRA. 
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Navigate the Open Waters of Regulations

With governing authorities still developing their own regulatory controls, manufacturers have new opportunities to shape the present and future landscape. At the same time, SaMD companies can control the unknowns and reduce barriers to compliance with our purpose-built QMS software that functions beyond general-purpose tools.
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Safe and Secure Software

Identify problems before they become disasters. Today, officials monitor cybersecurity measures for SaMD. A software bill of materials is one of the most powerful tools in your arsenal.

Built for Customers Like You

Establishing a QMS
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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
Culture of Quality
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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
Impress Auditors
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Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.
https://blog.greenlight.guru/hubfs/GG22_theme-files/accents_graphics_textures_etc/testimonial-slider/testimonialSlider_default-image_rs.jpg play

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 play

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
https://blog.greenlight.guru/hubfs/C2Dx-875x530-2.jpg play

Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.

Streamline Compliance. Focus on Innovation.

With the right QMS in place, you’ll have less to worry about and more time to spend developing safe and effective SaMD.

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