Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Australia is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Brazil is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Canada is utilizing MDSAP. Read More

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. Read More

Comprehensive regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way Japan is utilizing MDSAP. Read More

This course provides the basic knowledge to prepare for the Medical Device Single Audit Program (MDSAP). It helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global quality systems expert, Kim Trautman. Learn about the MDSAP audit model, grading nonconformances and regulatory transition timelines, to name just a few highlights. Read More