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 onthe market. The regulatory processes differ depending on what market is the aim. To releasemedical devices within the European Economic Area (EEA) the devices need to have a CEmarking affixed. To release within the United States approval or clearance from the FederalFood and Drug Administration (FDA) is needed. Regulations and requirements for both thesemarkets 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, manytimes 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 createaversion. 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 forcommercialization, meaning it needs to go through the regulatory processes. The SKRC haveever gone through any regulatory process before, which creates problems since the processes arecomplex. They experience problems due to lack of knowledge and understanding of theregulatory processes, as well as finding and interpreting information.The purpose for this thesis is to create understanding of the current problems in working with theregulatory processes for the American and the European market, and to create a way to help theSKRC go through these processes. The questions interesting in this thesis are: How doregulations pose a problem for release of medical devices, for small companies? How can thisproblem be aided?To assist the SKRC a guidebook to the regulatory processes has been created. The guidebook hasbeen viewed as a product, and to develop it different product development tools and techniqueshave 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 thedifferent regulations in an understandable way in the guidebook will make the regulatoryprocesses more graspable and help the SKRC release their devices to market.