Introduction
摘要
The medical device industry is a booming area of technological development that is advancing with breakneck speed. Since the original publication of this book, the FDA and the medical device industry have both undergone dramatic changes. This is often the case with a regulated industry affected by any number of factors, including legal and scientific precedent, funding, an ever-changing political landscape, scientific evidence, legal mandates, amongst many other factors. Flux and change are also to be expected in an industry with continuously evolving technology and solutions. The advent of artificial intelligence (AI) and the various ways that AI has been used with medical devices are contributing to revolutionizing the industry. Creative thought, in conjunction with ingenuity, can produce innovative medical devices that have immense value for the medical device company bringing the product to market