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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

The pre-submission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA. 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

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

ISO 14971 states that manufacturers shall establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is considered an integral part of a manufacturer’s QMS. This course presents the key foundations of the risk management process as defined in ISO 14971 and provides expert tips on how to navigate the process. 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

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