CDRH Releases New Learning Module on ISO 13485:2003

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new set of learning modules Friday on voluntary audit report submissions and how to utilize CDRH's new pilot program.

The learning section consists of an introductory video and five learning modules in both English and French.

The modules cover the following topics:

• GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma
• GD211 - Module 1 - Introduction
• GD211 - Module 2 - Information about the Manufacturer
• GD211 - Module 3 - Information about the Audit
• GD211 - Module 4 - Audit Findings
• GD211 - Module 5 - Conclusions

Read more:

CDRH - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

Regulatory Focus - FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions