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Greenlight-Guru-Quality-Management-Software

 

Make Quality a Strategic Asset for your Medical Device Company 

Get your devices to market faster with less risk and advance the success of your in-market devices with the only medical device quality management software (MDQMS).

 

Workflows aligned to FDA & ISO standards for medical device predefined processes

  • 21 CFR Part 11 Compliant
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971
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EASY TO USE
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FAST TO IMPLEMENT
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SCALES WITH YOUR TEAM
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SIMPLIFIES COMPLIANCE
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COMPREHENSIVE QUALITY MANAGEMENT SOLUTION

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BUILT-IN CONTROLS THAT ALIGN WITH 21 CFR PART 820 AND ISO 13485:2016

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FLEXIBLE REVIEW AND APPROVAL WORKFLOWS WITH PART 11 COMPLIANT AUDIT TRAIL AND E-SIGNATURES

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FULLY INTEGRATED DESIGN CONTROLS AND RISK MANAGEMENT ALIGNED TO ISO 14971 REQUIREMENTS

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ACHIEVE CLOSED-LOOP TRACEABILITY, ALL IN A SINGLE, NETWORK VIEW THROUGH MACHINE LEARNING

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DRIVE COLLABORATION WITH TASK MANAGEMENT, COMMENTS, AND NOTIFICATIONS

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ZERO EFFORT SYSTEM VALIDATION, AT NO ADDITIONAL CHARGE

 

 

 

"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."

 

 

- KEVIN MCLEOD, CEO AT C2D, INC 

 

 

 

“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”

 

- RYAN NOLAN, CO-FOUNDER AT PHOTONICARE

 
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