Transcription of FDA Medical Device Industry Coalition
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FDA Medical Device Industry Coalition
ISO 14971: Overview of the standard April 2, 2010. FDA Medical Device Industry Coalition ISO 14971: Overview of the standard Risk Management Through Product Life Cycle: An Educational Forum William A. Hyman Department of Biomedical Engineering Texas A&M University Medical devices . Application of risk management to Medical devices - 14 pages in body - 63 pages in 10 Annexes April 2010 2. William Hyman, 1. ISO 14971: Overview of the standard April 2, 2010. 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 Risk control Residual risk acceptability Report/documentation Post-production April 2010 4.
ISO 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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