The medical device industry is highly regulated due to the product risk to health. One of the regulated requirements is to establish and maintain a quality management system. Although the rest of the world complies with ISO 13485 standard, the United States requires compliance with the 21 CFR 820, Quality System Regulation (QSR).

The QSR, specifying current Good Manufacturing Practices (GMP) for medical devices, was established in 1997 based on the earlier structure of the ISO 9001 and 13485. Understanding the QSR is essential to ensure compliance with the United States regulatory requirements and to prepare for an eventual visit from the FDA.

OBJECTIVES

This course will provide participants with the following:

• Overview of the FDA and intention of the 21 CFR 820
• Up-to-date requirements of the 21 CFR 820
• Working knowledge in application to their organization
• Ability to prepare and host an FDA inspection

Course Length- 8 Modules
Time to complete- 5-7 hours

MDSAP Functional Statement: “To jointly leverage regulatory resources to manage an efficient, effective and sustainable single audit program focused on the oversight of a medical manufacturer’s quality management systems.”