Quality Systems Training

Who Should Attend

This course is designed for anyone who needs to understand how to meet the requirements of a global medical device quality system. Attendees might include R&D or engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; compliance and legal; and other cross-functional team members.

Course Content

At the end of this course, participants will be able to:

  • Describe the objectives of ISO 13485:2016 and FDA’s QSR
  • Identify the requirements of ISO 13485:2016 and FDA’s QSR
  • Apply the requirements of ISO 13485:2016 and FDA’s QSR
  • Identify the common elements found in global QMS requirements
  • Describe how to plan and prepare for FDA and Notified Body audits
  • Each participant that passes the testing will receive a certificate of training/competency


Provides insight into FDA 21CFR820 and ISO 13485:2016

  • Format:Online, Self-Paced Course, Weekly Live Q+A Sessions
  • Delivery Options & Discounts:Online, Self-Paced Course Only
  • Fee Includes:On-line Course, One-on-One Sessions with Experts, Weekly Live Q+A Sessions, Competency Test, Certificate of Competency
  • Accreditation: Prime Path Medtechâ„¢
  • Price:$695 Per Attendee. Call for Multi-Attendee and Group Pricing