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Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard. Note: Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.     Read More

This course bundle provides comprehensive medical device regulatory requirements for all five countries currently utilizing MDSAP audits in their regulatory framework: Australia, Brazil, Canada, Japan and the United States. These five separate courses can also be purchased individually. Read More

Post-market surveillance for manufacturers is covered in Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course. Read More

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

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