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The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. This course provides critical information to ensure mandatory reporters maintain compliance with the regulation. Read more

This course provides a comprehensive overview of Australia’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Australia is utilizing MDSAP.   Read more

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements. China’s medical device regulation program has evolved rapidly over the past two decades. This two-hour overview covers the changes and key aspects of the regulations as they pertain to both domestic and overseas manufacturers. Read more

This course provides a comprehensive overview of Brazil’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Brazil is utilizing MDSAP. Read more

This course provides a comprehensive overview of Japan’s medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Japan is utilizing MDSAP. Read more

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.   Please note, the course will be made available for 30 days from the date of purchase Read more

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