An intensive one-day training course on how to establish and improve compliance with the GMP regulations for medical device design and development.


The FDA Quality System Regulation, 21 CFR Part 820, and ISO 13485 both contain significant requirements in relation to Design Control.
In many cases manufacturers have not satisfactorily established full compliance with these regulations and have received adverse inspections, including issuance of FDA Form 483’s, Warning Letters and Import Alerts.


Learning Objectives

The course provides an opportunity to:

Course Format

The course presents the design control requirements comprehensively and uses interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course.

Delegates receive a "Certificate of Attendance”.


Contact us for detailed training agenda and prices