Minimizing the ambiguities in medical devices regulations based on software requirement engineering techniques

TLDR: This paper will present a method to minimize the ambiguities in MDR requirements based on requirement engineering techniques (user story and use case diagram) and this work will be evaluated by the critical-to-quality tree measurement technique.

Abstract: Trusted medical software devices, must comply with one of the healthcare regulations such as Food and Drug Administration (FDA), EU Medical Device Regulation (MDR), and Health Insurance Portability and Accountability Act (HIPAA). Since these regulations are enacted by law legislators and written in a legal text, these regulations are typically written with ambiguities. However, people have a different interpretation for the legal text for example, software developers faced challenges in identifying and understanding the regulatory requirements that are related to the software development process. Moreover, ambiguous in regulatory requirements play a big role in software compliance with regulatory particularly, when the requirements are legal text. In this paper, we intend to minimize the ambiguities in EU MDR requirements based on requirement engineering techniques in order to make MDR requirements clear and precise for software developers. In our previous work, we extracted the requirements of MDR that would affect the software development life cycle (SDLC) directly or indirectly. Herein, we will identify the ambiguity types in the extracted requirements of MDR. Moreover, this paper will present a method to minimize the ambiguities in MDR requirements based on requirement engineering techniques (user story and use case diagram). Finally, this work will be evaluated by the critical-to-quality tree measurement technique.