To embed, copy and paste the code into your website or blog: After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our series on Software as a Medical Device in Europe, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“ MDR”). INTRODUCTION: A NEW LIFE CYCLE-FOCUSED APPROACH MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can obtain the CE marking, the MDR deploys a product life cycle-focused approach, aiming to establish responsibilities of medical device companies throughout the life cycle of the product. While not all requirements are new, to ensure conformity of the MDSW with the MDR, detailed and partly enhanced requirements concerning quality management, risk management, clinical evaluation, and technical documentation must be complied with post-market for the time the MDSW is in service.