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DEALING WITH FDA 483’s, WARNING LETTERS, and …
fmdic.orgFDA Medical Device Industry Coalition DEALING WITH FDA 483’s, WARNING LETTERS, and OTHER ENFORCEMENT ACTIONS Presented by: David Furr Principal Consultant, FDC Services, LLC
FDA Medical Device Industry Coalition
fmdic.orgISO 14971: Overview of the standard April 2, 2010 William Hyman, Sc.D. 2 Contents Scope Terms and definitions General requirements Risk analysis Risk evaluation Risk control Residual risk acceptability Report/documentation Post-production April 2010 3 Contents Scope Terms and definitions General requirements Risk analysis Risk evaluation ...