MedTech Software Validation

Modern Validation for Modern QMS Software

Software validation is a heavy lift and a cumbersome process for even the most well-equipped MedTech companies. That’s why we've taken this on ourselves - to provide a premium experience and resources to ensure your team is meeting evolving validation requirements, so you can spend more time using the software and less time testing it.

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


Validating Your QMS Shouldn’t Be A Burden

Software validation has historically been an extensive and cumbersome process, even for the most well-equipped companies. Excessive documentation demands significant time and effort, resulting in countless hours spent outlining, testing, and reviewing software validation procedures. The MedTech industry and regulators recognize these burdens and the shift that must happen to simplify and streamline validation.


From Validation to Assurance

The industry is now advancing toward a more balanced, risk-based approach to software validation. With Greenlight Guru, get a trusted technology partner with a modern validation approach that aligns with evolving industry requirements.

Unlock New Efficiencies

With Greenlight Guru, you receive a complete validation package with every major update so you can ditch the unnecessary time spent on system validation documentation and more time on bringing safe, effective medical devices to market.

Embrace a Risk-Based Approach

Our automated validation process emphasizes data integrity, reduced risk, and product quality using a risk-based approach that considers factors of complexity, criticality, and hazards as directed by current FDA guidance.

Streamline Compliance

Meet the modern requirements for software validation. Greenlight Guru Validation Package has been created to reflect Computer Software Assurance and ISO/TR 80002-2:2017 requirements and best practices

Embrace the Digital Age

Benefit from the continuous innovation offered by leading SaaS technology partners building solutions that make the tedious elements of your job easier. 


Our Vendor Responsibility Model

Our purpose-built solution eliminates the hassle of validation and extensive configurations. With Greenlight Guru, you can focus on what you do best while we handle the heavy lifting.

We Provide: 

  • Automated testing as part of QMS software development
  • A complete Validation Package with automated test results, summaries, memos, and templates
  • Continuous communication and support with each update

You Manage: developing your devices and periodic reviews of updated software validation reports. 

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A Software Validation Package Built to Stand the Test

At Greenlight Guru, we see ourselves as a strategetic partner for your success in achieving compliance. We not only provide you with a purpose-built system but also offer a comprehensive Software Validation Package at no additional cost. Why? Because we understand that compliance is a fundamental requirement and we refuse to hinder your path to success.

Learn Why Every Customer Relies On Our Validation Package

With Greenlight Guru, you can spend your time building life-changing medical devices, rather than constructing complex validation protocols for software intended to help you. Our validation package does everything for you that software vendors should do.

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trusted by 1000 +

medical device companies

75 %

reduction in implementation time

1700 +

510(k) clearances and CE markings

Key Resources

Greenlight Guru Announces Modernized Software Validation Approach

A risk-based approach to software validation for efficient and effective compliance when implementing Greenlight Guru's QMS software.

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Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?

“A risk-based approach for establishing and maintaining confidence that software is fit for its intended use.”

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FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

What you’ve known and believed about computer system validation, software validation, and compliance is about to change for the better.

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