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

This course is designed to provide an overview of US regulatory requirements for advertising and promotion of medical devices, with a focus on FDA as well as the corresponding standards, policies, procedures, and guidelines that apply to advertising and promotional activities. Upon completion of this course, learners will understand how advertising and promotion are defined, the required elements of advertising and promotional materials including on social media platforms, roles and responsibilities, and the regulatory risks associated with advertising and promotional activities. Read more

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

According to Annex XIII, Part B, of the EU IVDR, manufacturers must proactively collect and evaluate performance and relative scientific data from the use of a device which bears a CE mark and is placed on the market or put into service in the European Union (EU) with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring continued acceptability of the benefit-risk ratio and detecting emerging risks on the basis of objective evidence.   This course provides insight into the terms associated with PMPF, and requirements relative to the development of a PMPF plan, the analysis of PMPF findings, documenting a PMPF evaluation report, and the nexus between PMPF to performance evaluation and risk management.  This brief, fundamental course would benefit anyone planning, conducting, or managing post-market surveillance activities within an IVD manufacturer particularly those new to the industry. Read more

Post-market surveillance for manufacturers is covered in EU MDR 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