Books by Peter J. (Partner in Metaphysis LLP Ogrodnik

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

Consists of practical, applied case studies relating to medical device design in industry. This title includes case studies that are presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices.