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

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

This course provides a comprehensive overview of the United States medical device regulatory framework, including both pre-market and post-market requirements. This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way the United States is utilizing MDSAP. Read more