BI&T May/June 2018

Understanding—and complying with—the quality-related regulatory changes facing medical device manufacturers is no small feat. The experts quoted in the May/June BI&T cover story describe it as a "tidal wave" of change and like being "on a moving sidewalk and each foot is going in a different direction." According to the Food and Drug Administration's (FDA's) Quality System Regulation, manufacturers are required to “establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured” and will conduct quality audits “to assure that the quality system is in compliance” with such requirements. One key for mastering the challenge of quality assurance is understanding how ANSI/AAMI/ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, fits in. First drafted in 2003 as a supplementary requirement to the 1994 ISO 9001 standard, 13485 was revised in 2016, and the FDA indicated in March that it was interested in making greater use of the standard. The experts agree that in order to succeed in the quest for quality, one must approach the challenge in a systematic way.

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