Developing a guide to regulations forthe Medical Device Industry

Abstract: All Medical devices are required to go through regulatory processes before they can be put on the market. The regulatory processes differ depending on what market is the aim. To release medical devices within the European Economic Area (EEA) the devices need to have a CE marking affixed. To release within the United States approval or clearance from the Federal Food and Drug Administration (FDA) is needed. Regulations and requirements for both these markets differ depending on device types and risks that may be associated with the device. The biggest problem with regulations is the big amount of information and how it is presented. The regulatory processes are based on a vast number of regulations and requirements, many times with cross references that lead to confusion. Especially for smaller companies, where nospecific person is assigned to these types of tasks, the processes can be overwhelming and create aversion. Gathering information regarding the regulations and the approval process of a specificproduct type is hard and can be very time consuming. The Sister Kenny Research Center (SKRC) has a new medical device ready for commercialization, meaning it needs to go through the regulatory processes. The SKRC have ever gone through any regulatory process before, which creates problems since the processes are complex. They experience problems due to lack of knowledge and understanding of the regulatory processes, as well as finding and interpreting information.The purpose for this thesis is to create understanding of the current problems in working with the regulatory processes for the American and the European market, and to create a way to help the SKRC go through these processes. The questions interesting in this thesis are: How do regulations pose a problem for release of medical devices, for small companies? How can this problem be aided? To assist the SKRC a guidebook to the regulatory processes has been created. The guidebook has been viewed as a product, and to develop it different product development tools and techniques have been used. The guidebook gives an overall understanding of the regulatory processes, instructions on tasks and references to where more information can be found. Presenting the different regulations in an understandable way in the guidebook will make the regulatory processes more graspable and help the SKRC release their devices to market.