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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 Prepare Your Organization for the Transition to ISO 13485:2016

The much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).

The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here.

ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”

The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.

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In this webinar, you'll learn specifically:
      • What your organization needs to be doing to prepare for the transition to ISO 13485:2016
      • Why the transition presents an opportunity for your organization to implement better processes
      • An overview of the specific changes coming with ISO 13485:2016
      • The actions you should be taking now and how to plan for the implementation of the standard

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Moderator/Presenter: Jon Speer

Founder, Greenlight Guru
loopMark

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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