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ISO 13485:2016 – Preparing for Implementation
ISO 13485:2016 will have a direct impact on your quality system including:
What do you need to know — and do — to remain compliant?
Industry expert Dan O’Leary — President of Ombu Enterprises, LLC — illustrates the revisions and explains the transition plans for the certificates from the current versions (ISO 13485:2003 and EN ISO 13485:2012) to the corresponding new versions(ISO 13485:2016 and EN ISO 13485:2016). Additionally, he’ll point out potential conflicts with the QSR.
In 90 minutes, you will learn:
Order today and begin preparing for implementation of ISO 13485:2016.
Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.
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