Miklos Biro

Refinement-Based Development of Software-Controlled Safety-Critical Active Medical Devices

Advanced medical devices exploit the advantages of embedded software whose development, due to their direct impact on human lives, is naturally subject to compliance with the stringent requirements of safety standards and regulations. This paper presents initial results and lessons learned from an ongoing project focusing on the development of a formal model of a sub-system of a software-controlled safety-critical Active Medical Device (AMD) responsible for renal replacement therapy. The use of formal approaches for the development of AMDs is highly recommended by standards and regulations, and motivates the recent advancement of the state of the art of related methods and tools including Event-B and Rodin applied in this paper. It is expected that the presented model and analysis will contribute to the still sparse experience base available at the disposal of the scientific and practitioner community in the domain of AMDs.

Need for the Continuous Evolution of Systems Engineering Practices for Modern Vehicle Engineering

Cars of the future (ADAS – Autonomous self-driving assistant) will need to cover a number of new standards for mechatronic design and networking of the car in the cloud. This includes job roles for ISO 26262, IEC 61508 (functional safety), SAE J3061 (cybersecurity), etc. For instance, a car driving on a street will exchange information with neighbouring cars and learn the right steering angle, speed, etc. while the driver is using the car like a work place. Manufacturers plan to produce from 2030 only cars which have such a self-driving function incorporated. The design of new electric cars will require new infrastructures, new energy management, new battery concepts, and also new materials design (light weight and still resistant), and the job role pool will include these key skills as well. The production of cars will be with connected plants, robots to be programmed, and central production servers to coordinate the industry 4.0 type of production virtually across the world. And the new cybersecurity norm SAE J3061 will develop further in the next years because by moving the cars to the cloud and the production to industry 4.0 leaves Europe’s industry vulnerable to attacks if this is not handled. Also the medical systems move towards an IoT (Internet of Things) approach where people receive implants which read out the data and transport them to the mobile which forwards the data to a medical service in the cloud where data are used by states and hospitals.

Aspects of improvement of software development lifecycle management

The software development lifecycle management is a crucial aspect of software development, as it defines significantly the effectiveness of development and the maturity of the final product. A suitable management system is especially important in safety critical development, such as the development of medical devices, as these developments have to be well documented to prove the safe operation of the given instrument. This paper prepares a case study to help a company improving their existing lifecycle management system by establishing a group of requirements. In particular, the paper focuses on medical device software development aspects. The answering of these questions allows achieving an optimal choice among the possible management systems either by providing a quantitative comparison or by highlighting the grounds for exclusion.

Abstract State Machines, Alloy, B, TLA, VDM, and Z

This book constitutes the refereed proceedings of the 5th International Conference on Abstract State Machines, Alloy, B, TLA, VDM, and Z, ABZ 2016, held in Linz, Austria, in May 2016. The 17 full and 15 short papers presented in this volume were carefully reviewed and selected from 61 submissions. They record the latest research developments in state-based formal methods Abstract State Machines, Alloy, B, Circus, Event-B, TLS+, VDM and Z

The Future of SPI Knowledge and Networking in Europe – A Vision

Authors of this paper have been founders of the EuroSPI (1994 – now, www.eurospi.net ) network with the first networking of SPI strategies published at CON’93 conference. They were also founders of the idea and establishment of a Europe wide certification network ECQA ( www.ecqa.org ) in 2005 (strategy development 2005 – 2007, online systems set up 2008 – 2009, Europe wide roll out since 2009). In a think tank and network of leading SPI experts we have developed the idea of a future European knowledge networking strategy and how the existing SPI paradigms will shift into a new SPI world applying new principles for collaboration, networking, and using new media which became available in the last 3-4 years.This vision will then impact about how we collaborate and implement SPI in the future.

Optimizing Resource Utilization by Combining Activities Across Process Instances

Resource-efficient business processes are a key asset of an organization in a competitive market environment. Current efforts address this issue either at the process schema level by specifying an optimal sequence of process activities or at the process instance level by optimizing resource utilization within a single running process instance.

The Usability Approach in Software Process Improvement

In the past years, efforts in the field of Software Process Improvement were increasingly focusing on human aspects realizing that people participating in the processes have a high impact on the success of any improvement. While these aspects are included in newer models and methodologies, it is still vague how Software Process Improvement can be made suitable for different people. In this paper, we propose a new approach: the application of usability methodology for Software Process Improvement. We present an overview of the people aspects in Software Process Improvement and introduce a methodology to apply usability methodology in this context. We also formulate ideas on how to adapt concrete improvement methods based on the usability methodology.

Evaluation criteria for application life cycle management systems in practice

The effective use of (human) resources and a mature product assumes the application of a software development life cycle (SDLC) management system which actively supports the process of development. A well-adjusted SDLC system is a prerequisite in safety-critical developments, such as the development of medical devices. Otherwise, the intensive documentation needed proving the correct and safe operation of the equipment cannot be fulfilled. The aim of this paper is to provide structured and mostly quantified criteria for companies which plan to establish newly an application life cycle management system or improve an existing one. The answering of these question helps making an objective and optimal choice among the different systems. Finally, this paper prepares a case study, where the application of these criteria will be demonstrated in practice.

Towards automated traceability assessment through augmented lifecycle space

The assessment and improvement of the satisfaction of traceability requirements during the development of software in general and of safety-critical software in particular is demanding and costly. The special requirements are reflected in software process related general and industry specific standards and the popular agile approaches as well. It is imminent, for practical and logical reasons, that there is a need for the automation of the assessment of the completeness and consistency of traceability as far as possible. In addition to highlighting experienced weaknesses of current either homogeneous or heterogeneous tool environments intending to support development lifecycle traceability, this paper outlines new solutions and suggests the exploitation of emerging technologies for the automation of traceability assessment and improvement.

Model-Driven Re-engineering of a Pressure Sensing System: An Experience Report

This article presents our experience in re-engineering a pressure sensing system – a subsystem often found in safety-critical medical devices – using the B formal method. We evaluate strengths and limitations of the B method and its supporting platform Atelier B in this context. We find that the current state-of-the-art of model-oriented formal methods and associated tool-sets, especially in automatic code generation, requires further improvement to be amenable to a wider deployment to industrial applications for model-driven engineering purposes.