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

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