Bundle of 5 Courses - Medical Devices Regulatory Requirements.
United States, Japan, Australia, Brazil, Canada
A comprehensive overview of each countries' Medical Device regulatory framework, including both Premarket AND Postmarket requirements. Learn what it takes to bring a product to market in each country and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how each country is utilizing MDSAP. Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard.
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4838-5532-9120, v. 1
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