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Medical Device Quality Management Systems 101

An overview of ISO 13485:2016, the US FDA QSR, and Other Important QMS Regulations. 

New to the medical device industry or simply need to brush up on QMS compliance? You probably have many questions that begin with what, where, why, and how. WHAT regulations do we need to follow? WHERE do they apply? WHY do we need to follow them? HOW do we start? In this White Paper we address these questions and more.