ISO 13485:2016: Ensuring a Smooth Transition through Effective Preparation

Release Date
August 31, 2017 10:00 AM - 11:00 AM EDT

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In 2016, significant revisions were made to the quality management standard ISO 13485, an internationally recognized standard for all medical product manufacturers. The updated changes to ISO 13485 – the first since 2003 – demonstrate the increasing Quality System requirements for the global medical device industry and how organizations must adhere to the forthcoming and revised standard.

Join NAMSA’s regulatory expert, Linda Mummah Schendel, Principal Medical Research Manager, on August 31 (10 – 11 AM Eastern Time) as we discuss the steps that medical device manufacturers should take now to effectively prepare for the new standard by the mandatory implementation date of 2019.
Highlighted will be best practices, suggestions and information surrounding the following:

Time will also be allotted for Q&A.