Medical Device Software: From Requirements to Certification

The role of software in healthcare is getting more and more pervasive. Nevertheless, manufacturers sometimes forget that these software are medical devices and must be certified according to the EU Medical Device Regulation 2017/745. In this work we propose a pipeline for developing a Medical Device Software (MDS) compliant with the regulations and certifiable. The pipeline includes the phase of requirements elicitation, risk assessment and analysis of effectiveness as key elements. The preparation of the technical file should be carried out in parallel with the MDS development. In the overall, it can be stated that the certification process starts with the conceptualization of the MDS and proceeds all along its design and implementation

Key Aspects to Teach Medical Device Software Certification

Certification of Medical Device Software (MDS) according to the EU Medical Device Regulation 2017/745 requires demonstrating safety and effectiveness. Thus, the syllabus of a course on MDS development must provide tools for addressing these issues. To assure safety, risk analysis has to be performed using a four-step procedure. Effectiveness could be demonstrated by literature systematic review combined with meta-analysis, to compare the MDS performances with those of similar tools

Design of a Service for the Management of Heart Failure Patients Using Telemedicine

The tremendous prevalence and mortality of heart failure (HF), along with the social and economic impact of its consequences, make an appropriate disease management utmost important. In this context, telemedicine offers promising possibilities. Current clinical guidelines and technological solutions do not address the problem of monitoring at-risk patients and patients affected by mild HF for prevention purposes. The goal of this work is to design a service based on a telemedicine framework for the management of heart failure patients. The proposed service grounds the monitoring of the patient on a custom multi-sensor array that we designed and developed for the purpose. The description of the processes involved in the service was carried out by means of Process Modelling tools, and in particular through Swim Lane Activity Diagrams. The results look promising for the implementation of the service in a real-life scenario. The main strength of the service resides in a) the use of noninvasive monitoring technologies to include patients with a mild HF or at-risk patients; and b) the integration of hospital and territory services to grant continuity and coherence in the treatment

Developing Medical Device Software in compliance with regulations

In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulatio