Establishing a small company's medical device quality system

Abstract

PurposeThe purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way.Design/methodology/approachWhen a company comes up with an innovation in medical device technology, where can it go from there to transfer its product into the hands of consumers? If the technology is patented, the company has the option to license it. Alternatively, the company may want to move forward with further product development and marketing on its own (whether patented or not). Getting a medical device into any market typically requires regulatory approval, which cannot be obtained without a quality system. This paper focuses on the foundations of establishing a quality system and obtaining certification and regulatory approval in Canada, the EU, and the USA, and is directed towards small medical device manufacturers. It describes the process within four phases that cover the initial start up, implementation of procedures, certification and regulatory approval, and continual improvement.FindingsEstablishing a quality system is a monumental task for any company, but especially so for a small one. However, the benefits of implementing a quality system outweigh the initial setbacks associated with doing so. The descriptions of phases in tandem with the DIY tips presented in this paper are intended to be of help to a small medical device manufacturer wanting to bring their innovative technology to consumers within a major marketplace.Originality/valueThis is an original paper written for the Third Canadian Quality Congress.