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This course includes six modules. The first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Regulation of Combination Products (21 CFR Part 4). Each module includes an approximately one-hour video instructional presentation by Kim Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video. Read More

Medical device regulators from around the world have recognized the importance of top management’s commitment to quality as essential to establishing and maintaining an effective quality management system.  Top management of medical device manufacturers have been held legally responsible for quality management system failures.  Top management is not simply the most responsible corporate officials, but also those responsible for site-specific activities throughout the organization.  When considering action, regulatory authorities may use a “wide net” when identifying top management.  It is essential that top management of all levels of an organization understand its obligations to quality.  Cognizant of the value of top management’s time, this approximately one-and-a-half-hour course was designed to efficiently focus on top management obligations relative to FDA’s Quality System Regulation and ISO 13485:2016.  This course does not simply focus on the requirements of the regulation and standard but provides insight into the expectations of the framers of those documents through discussions of the preamble to the quality system regulation, and TC 210 guidance relative to ISO 13485:2016.  These discussions and supporting examples provide valuable insight into how to comply with the cited regulation and standard requirements.   Read More

Comprehensive regulatory requirements including the regulatory framework, pre and post market requirements, and instruction on the way the U.S. is utilizing MDSAP. 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

In this approximately 30-minute self-paced course, you will be introduced to the importance of writing effective nonconformity statements during audits of medical device manufacturer quality management systems. Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements. Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias. Read More

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