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Fda Form 3514

Fda Form 3514

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Instructions and help about 3514 cdrh

hello everyone i'm jeff cole marketing and program coordinator at oregon bio thank you for joining our mini biopro lunch and learn today's topic is what manufacturers need to know about fda's asca program we'll call it asca and leading today's lunch and learn will be our panelists leo eisner and eric renka uh in the left corner of your screen is leo eisner the iec 60601 guy and leo is the principal regulatory and compliance consultant of eisner safety consultants he is a world renowned iec 60601 under medical electrical equipment expert and is involved in the development of the iec 60601 series where he serves on multiple committees including the interpretation committee leo has worked the fda to provide feedback on the ask pilot program the home health care guidance standards development and provided training on mutual performance for the 60601 series of standards leo and his team have helped countless clients through the compliance and regulato

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