Handbook of Medical Device Design

by RichardC.Fries (Author)

• New

  Hardcover
  2000

  $413.87

  Offering a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), and the ISO 9000 series, this book identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle.