Not using production units, lots, batches, or their equivalents.Not conducting any design validations to ensure finished device meets the intended use and end-user needs.Six common categories for the design validation warning letter citations are: 1 – The design and development process for medical devices.ĭesign validation has been the number one citation in FDA warning letters for design controls from 2011 to 2015. Is the device safe and effective for both the user and the patient?įig.Is the device’s usability easy, clear, obvious, and evident?.Does the device work in the user’s environment?.Some of the questions that need to be answered during design validation are: Successful design validation requires a thorough understanding of the user needs. It is at this stage that the medical device manufacturer confirms that the device that was designed is the right product that meets the needs of the user. Design validation is one of the most important aspects of the design and development process for medical devices.
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