Varicose veins is a condition, which affects numerous people. The condition is mostly not harmful but aesthetically unappreciated. Therefore many people choose to have them surgically removed. After the surgery is completed, the leg is bandaged, this for creating an ideal healing environment, without any complications occurring. It is important that a uniform pressure is distributed evenly along the bandaged leg, because high or low pressure can cause complications which prolongs healing. During the bandaging it is difficult to achieve an even pressure since the pressure varies due to the shape of the leg and who is bandaging the leg. PressCise has developed a compression bandage with a guide along the bandage, so that each bandaging will give the same pressure upon the leg. The bandage is designed after a specific mathematical formula that is derived from the law of Laplace. This means that no matter how thick or thin the leg is at different points, the pressure will distribute itself evenly over the entire bandaged leg. PressCise aims to obtain a CE-mark for the product before a launch. An analysis of demands and a wide test study therefor needs to be carried out. Demands and requirements for the product from different laws and regulations have been observed in order to determine which tests are necessary to execute. At this stage PressCise also needs to evaluate different parameters. To begin with, they need to see how the bandage behaves in different types of treatments, and secondly they need to evaluate the properties in order to give the correct information concerning usage and durability advices. In this report, a survey of the competitors was conducted in order to estimate which standards and tests the competitors are marketing their products with. An examination of the requirements of the product from the PressCise, CE marking and laws will be study, to see which demands and regulations lies upon the bandage. In this report a minor test study will be executed, where the product will go through a washing test, an abrasion test and a hysteresis test. The report will conclude with a requirement specification for the current product and its launching. / Program: Textilingenjörsutbildningen

On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. The main goal of MDR is to strengthen and improve the already existing legislation and thus will entail large changes for manufactures, one of them being manufacturers of Electronic Health Record (EHR) systems. For medical software, such as EHR systems, the new regulation will imply an upgrade in risk classification. This upgrade will bring additional requirements for EHR manufacturers. Furthermore, the released guidelines have been insufficient regarding the specific requirements for medical device software and thus EHR manufacturers are in need of tools and guidance to fulfill MDR. This thesis examines the new regulation for medical devices and thus identifies main requirements for EHR manufacturers. A qualitative approach was conducted comprising a literature study as well as a document study of the medical device regulation along with interviews with experts within the field of medtech regulatory affairs and quality assurance. The information gathered was analyzed to create a process description on how EHR manufacturers are to fulfill MDR. The process description is a general outline and presents the main steps on the route to be compliant with MDR in a recommended order of execution. The main steps are: divide the system into modules, qualify the modules, classify the modules, implement a quality management system, compile a technical documentation, compile the declaration of conformity, undergo a conformity assessment and finally, obtain the CE-mark. To each of the main steps additional documentation provides further information and clarification. The process description functions as a useful tool for EHR manufacturers towards regulatory fulfillment. Even though the process description is created for EHR manufacturers, it can be useful for other medical device software manufacturers. The process description provides an overview of the path to a CE mark and functions as a guidance. It can be used in educational purposes as well as to serve as a checklist for the experienced manufacturer to make sure everything is covered. However, it is not sufficient to rely solely on the process description in order to be in full compliance with MDR. Moreover, there is still a need for further clarifications from the European Commission regarding specific requirements on medical device software.