Is my medical software allowed to go to market?

Abstract

The central importance of software in healthcare practices is highlighted by the increasing regulation of medical software in order to safeguard medical activities and patient’s rights. Medical software suppliers need to meet regulatory requirements from different countries to gain market access and offer necessary compliant solutions. The present report focuses on providing methods and tools to allow software suppliers to evaluate which software products should be sold in which countries. Using design science and behavioral science two artifacts are presented integrating influence of regulatory requirements on market access and product lifecycle management. It is required to present all the regulatory information in an actionable way in order for it to be operationalized by businesses and engineering staff within a company.