Medical Device Design: Innovation from Concept to Market

Author: Peter J. Ogrodnik

Second Edition – A Comprehensive Guide to Medical Device Development

Medical Device Design: Innovation from Concept to Market, Second Edition, serves as a bridge between engineering design and medical device development. This book addresses the gap in the market for a single text that covers the myriad of design issues that medical devices designers encounter when developing new products or improving existing ones.

Regulatory Requirements: FDA and EU

The book covers the regulatory requirements for medical devices, including FDA regulations and EU Medical Device Regulation. It provides essential methodologies that medical designers must understand to ensure their products meet these requirements, bringing together proven design protocols to enable engineers and medical device manufacturers to quickly bring new products to the market.

From Concept to Commercialization: A Comprehensive Guide

This unique book takes the reader through the entire process of medical device development, from the early stages of conceptualization to commercialization on the global market. It is an invaluable resource for both professionals and newcomers to device design.

Updated Standards and Regulations: ISO 13485:2016 and More

The book includes updated information on standards and regulations, including ISO 13485:2016, FDA regulations, and the European Medical Device Regulation.

New Case Studies: Classification, Design Process, Quality, Labeling, and More

It also presents new case studies in various areas, such as classifying medical devices, the design process, quality, labeling, instructions for use, and more.

Software and Biocompatibility Concerns: Additional Content

Additional content is provided around software and biocompatibility concerns, making this book a comprehensive guide for medical device designers and manufacturers.

Product Details:

Publisher: Elsevier Science

Publication Date: October 30, 2019

Language: English

ISBN: 9780128149621, 9780128149638