An Introduction to Implementing and Understanding ISO 13485:2016 and GMP/FDA requirements for use in the Medical Device Industry

This one hour session will give employees an introduction to using, implementing ISO 13485:2016 and the GMP requirements for use in the Medical Device Industry. We will review what are some of the current requirements, some of the necessary training that employees should have and how to use ISO 13485:2016 and the GMP requirements to work effectively in the Medical Device Industry. There will also be a review of the options for using 3rd Party registration as well as how to get help supporting this industry. In addition, there will also be a discussion on how a company can leverage their current QMS to achieve ISO 13485:2016 and GMP compliance.

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