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Course Description: This fully online 2-day course is a highly interactive training that includes case study exercises, competency assessment, and Certificates of Completions. This course will provide an understanding of the risk management standard (ISO 14971:2019). By the end of the training, students will be able to: Evaluate the fundamental requirements from medical device regulation relating to risk management Discover ISO 14971 step-wise approach to risk identification, assessment, control and evaluation Develop specific knowledge on how to implement risk management within the Product development, Product Manufacturing and Post Market phases of a product lifecycle Establish Risk Acceptability criteria Learn risk management tools and activities from defining product characteristics to the preparation of risk management summaries for regulatory submission. Discover the tools, techniques, information and records required to develop a successful risk management program and use as a basis for US regulatory reviews Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Australia is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Brazil is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Canada is utilizing MDSAP. Read More

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements. China’s medical device regulation program has evolved rapidly over the past two decades. This two-hour overview covers the changes and key aspects of the regulations as they pertain to both domestic and overseas manufacturers. Read More

COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing Purchase this package for FDA Establishment Registration and Product Listing if you are a US based company.   If you need NSF as your US Agent, please use the following link to purchase the version with US Agent Services. COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing - Includes US Agent Service: https://nsfmedicaldevices.trainingfolks.com/store/819777-covid-19-hand-sanitizer-temporary-fda-registration-listing-includes-us-agent-service-511-a   Below is a recording of a webinar by Maxine Fritz and Ori Dezsi about FDA's policy for Hand Sanitizer.   ENGLISH SPANISH   Read More

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