MDSAP Overview and Country-Specific Medical Device Regulations: 5-Course Bundle

On-Demand12 hours

Course Overview

This six-course bundle provides an overview of the Medical Device Single Audit Program (MDSAP) and country-specific medical devices regulatory requirements for the United States, Japan, Australia, Brazil and Canada.

Learn what it takes to bring a product to market in each country and keep it there. We cover pre- and post-market requirements, as well as how each country utilizes MDSAP.

NSF’s web-based virtual training course provides the basic knowledge to prepare for MDSAP, helps key personnel realize the urgency of MDSAP readiness and offers answers to vital questions direct from global quality systems expert Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Kim also authored and led the implementation of the current U.S. FDA quality system regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485.

Competency assessments provide documented evidence for the training requirements.

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