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