ISO 13485:2016 and Country-Specific Medical Device Regulations: 6-Course Bundle


12 hours

Course Overview

Bundle of 6 courses: ISO 13485:2016 Overview and Country-Specific Medical Devices Regulatory Requirements for 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.

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 regarding Clause 4-QMS, Clause 5-Management Responsibility, Clause 6-Resource Management, Clause 7-Product Realization and Clause 8-Measurement Analysis and Improvement.