REQUIRED (Student must provide):
Attendees must obtain a copy of the standard ISO 13485:2016 Medical Devices – Quality Management System Requirements for Regulatory Purposes, which will be used during the course.
The standard may be purchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).
PROVIDED (Student will receive):