A comprehensive overview of Canada's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the Canadian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Canada is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard. Read More

A comprehensive overview of Japan's Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the Japanese market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Japan is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard. Read More

A comprehensive overview of the U.S. Medical Device regulatory framework, including both Premarket AND Postmarket requirements.  Learn what it takes to bring a product to the U.S. market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how the U.S. is utilizing MDSAP.  Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard. Read More

The Q-Sub program is a voluntary mechanism to get FDA’s feedback on specific questions necessary to guide product development and/or application preparation. The idea behind the Q-Submission program is not new and in fact, has often been a critical part of premarket review. However, a comprehensive system for FDA feedback mechanisms had not been well-defined prior to FDA's recent guidance documents issued in 2017 and 2018. In this course we will review these guidance documents and the recommendations provided within to make your next request for FDA feedback more effective and productive. 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 Combination Products Regulation (21 CFR Part 4.) Each module includes an approximately one-hour video instructional presentation by Kimberly Trautman, Executive Vice President, Medical Device International Services at NSF International, followed by an assessment on the information covered in the video. Kimberly Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She led international initiatives for the U.S. FDA including conceiving, developing and launching the international Medical Device Single Audit Program. She wrote the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and led the implementation associated with the QS regulation. She also led the harmonization efforts for ISO 13485 since its inception in 1994, serving as international delegate to ISO/TC 210 and the U.S. Technical Advisory Group co-chair for ISO/TC 210. Read More

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