Design Controls White Paper Series

Paper 7: Design Change and Design History File

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Cognition's Design Controls Series

Paper 7: Design Change and Design History File

DC_Series_Paper_7_SS-1.pngThe FDA requires medical device manufacturers to follow a strict set of guidelines in order to ensure compliance and safety for all devices going to market. These regulations and guidelines are confusing to understand and poorly implemented within industry. This often leads to FDA issuing Form 483s and Warning Letters to manufacturers out of compliance. This new white paper aids in understanding the failures many face as well as best practices to avoid and overcome them.

Download the seventh and final white paper in our Design Controls Series: Design Changes and Design History File

  • Detailed breakdown of 483s and warning letters issued due to problems with design change and Design History File
  • Outlines best practices for avoiding warning letters and 483s from FDA