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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 CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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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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FREE ON-DEMAND WEBINAR

A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immediately.

We’re in the window where there is less than a year until you need to be ISO 13485:2016 certified. There is no extension. ISO won’t accept any excuses - this has been published for at least two years now.

In this free 60 minute webinar, Jon Speer, a 20+ year medical device industry veteran and founder & VP QA/RA at Greenlight Guru will be sharing with you an action plan to get ISO 13485:2016 certified if you haven't begun the transition process yet.

Watch the webinar
ISO 13485-2016 Timeline Webinar
Specifically, you will learn:
  • An overview of a timeline of activities you'll need to perform
  • What happens if you don't get certified in time 
  • Best practices and a transition plan 
  • What auditors will be looking for in your stage 1 and stage 2 certification audits 
  • How to ensure all your quality processes are now "risk-based" 
Who Should Attend?
  • Medical Device Executives
  • Quality Assurance and Quality Control
  • Regulatory Affairs and Compliance
  • Manufacturing
  • Supplier Management
  • Internal, External and Quality Auditors
  • Document Control
  • Production
  • Operations
  • Suppliers to the Medical Device Industry
  • R&D / Product Development
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Moderator/Presenter: Jon Speer

Founder, Greenlight Guru
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About Greenlight Guru

Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices.

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