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 has been designed and manufactured to be safe, effective and reliable. The manufacturer warranties the device for a certain period of time, usually 1 year. Is this the end of the manufacturer’s concern about the device? It should not be. There is too much valuable information to be obtained.
