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Medical Device Design

- Innovation from Concept to Market

About Medical Device Design

Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

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  • Language:
  • English
  • ISBN:
  • 9780128149621
  • Binding:
  • Paperback
  • Pages:
  • 538
  • Published:
  • October 25, 2019
  • Edition:
  • 2
  • Dimensions:
  • 234x191x33 mm.
  • Weight:
  • 1066 g.
  In stock
Delivery: 3-5 business days
Expected delivery: August 16, 2025

Description of Medical Device Design

Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

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