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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 26 March 2012 | By Alexander Gaffney, RAC
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:
CDRH - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program
Regulatory Focus - FDA Launches Pilot Program for ISO 13485:2003 Audit Report Submissions
Tags: CDRH Learn, Module, ISO 13584:2003, Pilot, Latest News, program, medical device