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How Does This Alliance Help To Mitigate Risk?

The strategic alliance allows medical device companies to gain expert biocompatibility advice for their product design early on. This helps them mitigate risk by eliminating potential toxic materials during the design phase to ensure success by bringing their devices into compliance and to the market faster.

Nelson Labs Expert Advisory Services team can leverage this seamless consolidated information stream within Greenlight Guru to provide holistic support as medical device companies transition from planning to product development and testing.

 


Alliance Benefits Package

Regulatory Compliance Consulting

  • Regulatory support for submissions, product changes, or rejection notices
  • Test plans, protocols, and written justifications for lab method selection

Biological Evaluation Planning & Consulting

    • Review existing BEP for your device
    • Guidance on creating a world-class BEP
    • Eliminate unnecessary testing
  • $125,000 saved on average cost estimated per project
  • Improved culture during project cycle
  • 2.5 months faster to market

 

 

  • 402 hours saved on low value-added activities
  • Single source of truth for all quality processes
  • Better audit readiness

 

 

About Greenlight Guru

green check Started in 2013 by medical device industry veterans
green check Only True MDQMS with fully connected Design Controls & Ris
green check Headquartered in Indianapolis, IN
green check Hundreds of customers on six continents

 

Carlys Version - Best QMS Software Ultimate Guide to Comparing Quality Management System Solutions
 
 
The only Medical Device QMS Solution Provider To Be Named A Category Leader By G2 Crowd SEVEN Quarters In A Row
 
 
 
 

EASY TO USE, FAST TO IMPLEMENT MEDICAL DEVICE QUALITY MANAGEMENT SOFTWARE THAT CONNECTS DISPARATE PROCESSES, SOURCES, PEOPLE, AND DATA FOR THE FIRST TIME EVER. INCREASED VISIBILITY SMOOTHS YOUR PATH TO COMPLIANCE AND LETS YOU FOCUS ON TRUE QUALITY.

  • Achieve End-to-End Traceability
  • Automate Quality, Risk, & Design Processes
  • Follow FDA & ISO Best Practices
  • Streamline Team Communication

 

Discover the power of end-to-end traceability ↓↓

 

 

 

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green-quotes Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA Submission. 

 

ryan-nolan
Ryan Nolan
Co-Founder & VP of Clinical Operations PhotoniCare

 

 

 

 

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green-quotes We wanted a QMS that was robust enough to grow with us, but simple enough to get us started.  

 

kevin-mcleod
kevin mcleod 
ceo at c2dx, inc

 

 

 

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