Software System Architecture Development in a Regulated Environment

The main goal of this thesis was a research of requirements and methods for software system architecture development and description in the field of medical and in vitro diagnostic (IVD) medical device manufacturing. The work was conducted for a company as a part of a product development project during transition periods of European medical and IVD medical device regulations, which came into force in May 2017. Due to the new laws and other changes in the regulated environment, to the objectives of the study were included reviewing of product and software development standard operation procedures (SOPs) of the company and recommending updates to those and researching the new regulations for an analysis of responsibilities for manufacturers who supply components to IVD medical device systems. The focus in the first part of the theory section of the thesis is on the new laws and on harmonised standards related to the laws. Standard ISO 13485 and IEC 62304 are highlighted, as they are the most relevant ones for product and software development. The second part of the theory concentrates on architecture development generally and particularly for medical device software. The method for the architecture description was applying of commonly known architecture view model and unified modelling language (UML) diagrams. The analysis of the company SOPs produced several suggestions for improvements. The question of responsibilities for manufacturers supplying components to IVD systems was answered based on literature review of the new regulations. The views to the architecture were documented using a modified version of a commonly known view documentation template. The architectural design emerged to a model driven and event driven software system architecture utilizing architectural patterns suitable for embedded systems. The type of system is a typical materialization of a medical device. The outcomes of the study were evaluated qualitatively. Method for the evaluation was interviewing. The interviewees were from the company and represented various stakeholders of the project and the thesis. All of them found the level of significance of the study high and considered the thesis to be well structured and of good quality