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

View the Free On-Demand Webinar

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.

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


About greenlight guru

Greenlight Guru is the only Quality Management Software designed exclusively for medical device companies allowing them to bring safer devices to market faster while reducing risk and ensuring compliance.



Founder & VP QA/RA
Greenlight Guru