This 10-hour course bundle provides a comprehensive overview of the medical device regulatory requirements for all five countries currently participating in the MDSAP program, a requirement for all manufacturers utilizing audits.
MDSAP Countries include: Australia, Brazil, Canada, Japan and the United States. (Each of the five courses can also be purchased individually.)
Learn what it takes to bring a product to market in each MDSAP-participating country and keep it there. We introduce the Medical Device Single Audit Program (MDSAP) and cover pre- and post-market requirements, and explain how each country utilizes MDSAP in its regulatory framework.
Our global medical device experts ensure content is up to date, highly interactive and designed with a visual learner in mind. These courses offer one-of-a-kind training developed by device experts and former regulators from around the globe. We provide English translations of regulations that are very difficult to locate, specifically Brazil and Japan.
Competency assessments provide documented evidence for the training requirements of ISO 13485, the international quality management system standard for medical devices.
A unique course offering that is vital for any medical device professional looking to bring products to market, or to manufacture or audit products in one or more MDSAP-participating country. These courses are particularly helpful for employees responsible for regulatory compliance, including developing premarket submissions for market entry and preparing for Quality System audits. Those interested in becoming an auditor under MDSAP can take these courses to demonstrate knowledge and competency in country-specific medical device requirements.