ABSTRACT

The goal of the Product Development process is to put a safe, effective and reliable medical device in the hands of a physician or other medical personnel where it may be used to improve health care. The device was designed and manufactured to be safe, effective and reliable. The manufacturer warranties the device for a certain period of time, usually one year. Is this the end of the manufacturer's concern about the device? It should'nt be. There is too much valuable information to be obtained.