Upcoming Sessions

See All Upcoming Sessions

COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing – Includes US Agent Service (511-A) Purchase this package for FDA Establishment Registration and Product Listing if your business is located outside of the US and you require NSF to serve as your US Agent (a requirement for non-US company seeking to market drug product in the US).   If you do not need NSF to be your US Agent, please use the following link to purchase the version without US Agent Services. COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing: https://nsfmedicaldevices.trainingfolks.com/store/819849-covid-19-hand-sanitizer-temporary-fda-registration-listing-511   Below is a recording of a webinar by Maxine Fritz and Ori Dezsi about FDA's policy for Hand Sanitizer. ENGLISH SPANISH   Read More

Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and provides an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. Read More

The FDA is aware of some confusion surrounding the guidance, Deciding When to Submit a New 510(k) for a Change to an Existing Device. As such, FDA has worked diligently over the past few years to enhance predictability, consistency and transparency while maintaining a “least burdensome approach.” The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations. In this course we walk through these changes and discuss how to determine when to submit. Read More

This video-based training course provides a basic understanding of design controls for medical devices and IVDs. It covers how to comply with the U.S. FDA’s Quality System Regulation, the quality management system international standard ISO 13485:2016 and EU MDR. Learn from global quality systems expert Kim Trautman, a former U.S. FDA official. Read More

This course provides comprehensive instruction on the EU IVDR. It covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.​ Read More

This course provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.   Read More

Shopping Cart

Your cart is empty