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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

How to Simplify Your Compliance with the New ISO 13485:2016 Quality Management Standard

Early in February 2016, ISO released its long awaited revision to 13485, the global standard for medical device quality management systems.

This is the first revision of the standard since 2003, and it represents some major changes including the inclusion of risk management throughout the QMS, greater emphasis on quality management throughout the entire product lifecycle and supply chain, and much more.

While there is a three year transition period to the new standard, the best medical device companies understand the benefits and advantages for beginning their transition now.

In this free webinar, Jon Speer, an 18+ year medical device industry veteran and founder & VP QA/RA at greenlight.guru, will be providing a detailed overview of all the changes as well as provide a set of actions you should be taking now to plan for the implementation of the new standard along with some tips and pointers to help simplify your transition.

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Specifically, you will learn:
      • What exactly has changed in the new ISO 13485:2016
      • Why putting off compliance until later could cost you
      • How leveraging technology can help simplify your compliance
      • 5 steps to take now to make for a smooth transition
Who Should Attend?
      • 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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