Towards RegOps: A DevOps Pipeline for Medical Device Software

Research output: Chapter in Book/Report/Conference proceedingConference contributionScientificpeer-review

Abstract

The manufacture of medical devices is a strictly regulated domain in the European Union. Traditionally, medical software compliance activities have been considered manual, document-centric, and burdensome. At the same time, over the last decade, software companies have maintained competitiveness and improved by relying on essential practices of DevOps, such as process automation and delivery pipelines. However, applying the same principles in medical software can be challenging due to regulatory requirements. In this paper, we utilize a systematic approach to align the essential medical device software regulatory requirements from the standards IEC 62304 and IEC 82304-1 and integrate them into the software delivery pipeline, which is the main contribution of our work. The outcome supports practitioners to establish more efficient software delivery models while maintaining compliance with the medical device standards.

Original languageEnglish
Title of host publicationProduct-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings
EditorsLuca Ardito, Andreas Jedlitschka, Maurizio Morisio, Marco Torchiano
PublisherSpringer
Pages290-306
Number of pages17
ISBN (Electronic)9783030914523
ISBN (Print)9783030914516
DOIs
Publication statusPublished - 2021
Publication typeA4 Article in conference proceedings
EventInternational Conference on Product-Focused Software Process Improvement - Virtual, Online
Duration: 26 Nov 202126 Nov 2021

Publication series

NameLecture Notes in Computer Science
Volume13126
ISSN (Print)0302-9743
ISSN (Electronic)1611-3349

Conference

ConferenceInternational Conference on Product-Focused Software Process Improvement
CityVirtual, Online
Period26/11/2126/11/21

Keywords

  • DevOps
  • Medical device software
  • Medical device standards
  • RegOps
  • Regulatory compliance

Publication forum classification

  • Publication forum level 1

ASJC Scopus subject areas

  • Theoretical Computer Science
  • Computer Science(all)

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