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  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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