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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‘Medical Device Design - Ogrodnik, Peter J. (Partner in Metaphysis LLP, Award Leader MSc Medical Engneering Design at Keele University, Honorary Professor Guangxi University of Science and Technology)’.
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