When: « Back to Calendar August 31, 2017 @ 10:00 am - 11:00 am
Where: Webinar
Categories: Other Events of Interest

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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:

  • Understand when device manufacturers will be required to comply with ISO 13485, and if there are any exceptions
  • Learn about the top ten (10) changes that should be considered when identifying a compliance strategy
  • Discover approaches that product makers can utilize to effectively address the new standard
  • Understand the role of risk management and how it may impact implementation
  • Uncover, and maximize, the benefits of ISO 13485

Time will also be allotted for Q&A.

For more information Click-Here