Medical Device Single Audit Program
1 Medical Device Single Audit Program CAPT Kimberly Lewandowski-Walker . FDA/ORA/Office of Medical Products and Tobacco Operations . National Expert, Medical Devices
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FDA Medical Device Industry Coalition
fmdic.orgISO 14971: Overview of the standard April 2, 2010 William Hyman, Sc.D. 1 FDA Medical Device Industry Coalition ISO 14971: Overview of the standard
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fmdic.org•Nonconforming Material Reports •Equipment Data •Scrap/Yield Data •Rework Data •Returned Product •Internal Audits •Process Control Data •Acceptance Activities EXTERNAL SOURCES INTERNAL SOURCES
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