21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)

The medical device market in the USA is lucrative but tightly regulated and controlled. The standard that controls the manufacturing and marketing of medical devices in the US market is known as 21 CFR Part 820. Created by the FDA, this regulation requires medical device manufacturers to develop a Quality Management System.

Using their expertise in the regulatory market, the course development experts at Exoexcellence Consultants have developed this course that explains all the major and minor aspects of 21 CFR Par 820. Comprising two modules, this course has been designed for Alison students interested in regulatory affairs, especially the ones concerned with medical device manufacturing. This course will also help professionals already in this field by upscaling their skills.

The first introduces the learners to the standard and explains all its subparts. It also discusses the importance of a robust QMS for the medical device manufacturing industry. The second module helps students revise all the subparts in a simplified way. Then, it explains the methods medical device manufacturers use to show compliance with 21 CFR Part 820. This module also compares ISO 13485 with 21 CFR Part 820. It also explains how manufacturers can prepare themselves for the FDA inspection process. By taking this course, students can not only establish themselves by upgrading their skills, but they can also work as regulatory consultants for medical device manufacturers,