This six-course bundle provides an overview of ISO 13485:2016 and the 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.
This course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe. This course covers the goals of the standard and detailed information on Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.
Competency assessments provide documented evidence for the training requirements.