CompliancePal: A Tool for Supporting Practical Agile and Regulatory-Compliant Development of Medical Software

As digital transformation affects more and more industries, the increased role of software and the skills required to develop software trigger a ripple effect. Entire industries, where regulations and government standards play an important role (e.g. health care, avionics, etc.), have used long development cycles that relied on detailed up-front planning before advancing to any detailed decision. In contrast to this mindset, agile software development has proven to deliver results that satisfy customers needs faster than traditional waterfall methodologies. The lack of detailed upfront planning and fast delivery cycles have led to situations where the use of agile became synonymous with lack of documentation and poor quality, and hence the perception that the approach is not suitable for regulated systems. In this experience paper we describe the implementation of a service that integrates medical device software compliance specific activities such as architectural design and limited risk management into the daily agile practices of a software development team.Peer reviewe

Towards Agile Yet Regulatory-Compliant Development of Medical Software

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On Medical Device Software CE Compliance and Conformity Assessment

Manufacturing of medical devices is strictly controlled by authorities, and manufacturers must conform to the regulatory requirements of the region in which a medical device is being marketed for use. In general, these requirements make no difference between the physical device, embedded software running inside a physical device, or software that constitutes the device in itself. As a result, standalone software with intended medical use is considered to be a medical device. Consequently, its development must meet the same requirements as the physical medical device manufacturing. This practice creates a unique challenge for organizations developing medical software. In this paper, we pinpoint a number of regulatory requirement mismatches between physical medical devices and standalone medical device software. The view is based on experiences from industry, from the development of all -software medical devices as well as from defining the manufacturing process so that it meets the regulatory requirements.Peer reviewe

Towards Regulatory-Compliant MLOps: Oravizio’s Journey from a Machine Learning Experiment to a Deployed Certified Medical Product

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Quantum Software Engineering Challenges from Developers' Perspective: Mapping Research Challenges to the Proposed Workflow Model

Despite the increasing interest in quantum computing, the aspect of development to achieve cost-effective and reliable quantum software applications has been slow. One barrier is the software engineering of quantum programs, which can be approached from two directions. On the one hand, many software engineering practices, debugging in particular, are bound to classical computing. On the other hand, quantum programming is closely associated with the phenomena of quantum physics, and consequently, the way we express programs resembles the early days of programming. Moreover, much of the software engineering research today focuses on agile development, where computing cycles are cheap and new software can be rapidly deployed and tested, whereas in the quantum context, executions may consume lots of energy, and test runs may require lots of work to interpret. In this paper, we aim at bridging this gap by starting with the quantum computing workflow and by mapping existing software engineering research to this workflow. Based on the mapping, we then identify directions for software engineering research for quantum computing.Comment: 4 pages, 1 figur

Extending SOUP to ML Models in Certified Medical Systems

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MLOps Challenges in Multi-Organization Setup: Experiences from Two Real-World Cases

Workshop on AI Engineering - Software Engineering for AI , WAIN ; Conference date: 30-05-2021 Through 31-05-2021Peer reviewe

Toward Multiconcern Software Development With Everything as Code

As software is becoming a central element in our lives, more stakeholders have concerns. Unlike today, when developers stop their coding activities to satisfy these stakeholder concerns, we propose dealing with them as a part of the coding workflow.Peer reviewe