Towards RegOps: A DevOps Pipeline for Medical Device Software

Henrik Toivakka; Tuomas Granlund; Timo Poranen; Zheying Zhang

doi:10.1007/978-3-030-91452-3_20

Towards RegOps: A DevOps Pipeline for Medical Device Software

Henrik Toivakka^*
, Tuomas Granlund
, Timo Poranen
, Zheying Zhang

^*Corresponding author for this work

Computing Sciences

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › Scientific › peer-review

10 Citations (Scopus)

449 Downloads (Pure)

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 language	English
Title of host publication	Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings
Editors	Luca Ardito, Andreas Jedlitschka, Maurizio Morisio, Marco Torchiano
Publisher	Springer
Pages	290-306
Number of pages	17
ISBN (Electronic)	9783030914523
ISBN (Print)	9783030914516
DOIs	https://doi.org/10.1007/978-3-030-91452-3_20
Publication status	Published - 2021
Publication type	A4 Article in conference proceedings
Event	International Conference on Product-Focused Software Process Improvement - Virtual, Online Duration: 26 Nov 2021 → 26 Nov 2021

Publication series

Name	Lecture Notes in Computer Science
Volume	13126
ISSN (Print)	0302-9743
ISSN (Electronic)	1611-3349

Conference

Conference	International Conference on Product-Focused Software Process Improvement
City	Virtual, Online
Period	26/11/21 → 26/11/21

Funding

The authors would like to thank Business Finland and the members of AHMED (Agile and Holistic MEdical software Development) consortium for supporting this work.

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
General Computer Science

Access to Document

10.1007/978-3-030-91452-3_20

PROFES_21__Towrds RegOps_Continuous_Delivery_of_MD
This publication is copyrighted. You may download, display and print it for Your own personal use. Commercial use is prohibited.
Accepted author manuscript, 357 KBLicence: Unspecified

https://urn.fi/URN:NBN:fi:tuni-202202021795Licence: Unspecified

Cite this

Toivakka, H., Granlund, T., Poranen, T., & Zhang, Z. (2021). Towards RegOps: A DevOps Pipeline for Medical Device Software. In L. Ardito, A. Jedlitschka, M. Morisio, & M. Torchiano (Eds.), Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings (pp. 290-306). (Lecture Notes in Computer Science; Vol. 13126). Springer. https://doi.org/10.1007/978-3-030-91452-3_20

Toivakka, Henrik ; Granlund, Tuomas ; Poranen, Timo et al. / Towards RegOps : A DevOps Pipeline for Medical Device Software. Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings. editor / Luca Ardito ; Andreas Jedlitschka ; Maurizio Morisio ; Marco Torchiano. Springer, 2021. pp. 290-306 (Lecture Notes in Computer Science).

@inproceedings{f58a413602404c439f981c6b5c61b3c4,

title = "Towards RegOps: A DevOps Pipeline for Medical Device Software",

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.",

keywords = "DevOps, Medical device software, Medical device standards, RegOps, Regulatory compliance",

author = "Henrik Toivakka and Tuomas Granlund and Timo Poranen and Zheying Zhang",

note = "Funding Information: The authors would like to thank Business Finland and the members of AHMED (Agile and Holistic MEdical software Development) consortium for supporting this work. Publisher Copyright: {\textcopyright} 2021, Springer Nature Switzerland AG. JUFOID=62555; International Conference on Product-Focused Software Process Improvement ; Conference date: 26-11-2021 Through 26-11-2021",

year = "2021",

doi = "10.1007/978-3-030-91452-3\_20",

language = "English",

isbn = "9783030914516",

series = "Lecture Notes in Computer Science",

publisher = "Springer",

pages = "290--306",

editor = "Luca Ardito and Andreas Jedlitschka and Maurizio Morisio and Marco Torchiano",

booktitle = "Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings",

}

Toivakka, H, Granlund, T , Poranen, T & Zhang, Z 2021, Towards RegOps: A DevOps Pipeline for Medical Device Software. in L Ardito, A Jedlitschka, M Morisio & M Torchiano (eds), Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings. Lecture Notes in Computer Science, vol. 13126, Springer, pp. 290-306, International Conference on Product-Focused Software Process Improvement, Virtual, Online, 26/11/21. https://doi.org/10.1007/978-3-030-91452-3_20

Towards RegOps: A DevOps Pipeline for Medical Device Software. / Toivakka, Henrik; Granlund, Tuomas ; Poranen, Timo et al.
Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings. ed. / Luca Ardito; Andreas Jedlitschka; Maurizio Morisio; Marco Torchiano. Springer, 2021. p. 290-306 (Lecture Notes in Computer Science; Vol. 13126).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › Scientific › peer-review

TY - GEN

T1 - Towards RegOps

T2 - International Conference on Product-Focused Software Process Improvement

AU - Toivakka, Henrik

AU - Granlund, Tuomas

AU - Poranen, Timo

AU - Zhang, Zheying

N1 - Funding Information: The authors would like to thank Business Finland and the members of AHMED (Agile and Holistic MEdical software Development) consortium for supporting this work. Publisher Copyright: © 2021, Springer Nature Switzerland AG. JUFOID=62555

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - DevOps

KW - Medical device software

KW - Medical device standards

KW - RegOps

KW - Regulatory compliance

U2 - 10.1007/978-3-030-91452-3_20

DO - 10.1007/978-3-030-91452-3_20

M3 - Conference contribution

AN - SCOPUS:85121630016

SN - 9783030914516

T3 - Lecture Notes in Computer Science

SP - 290

EP - 306

BT - Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings

A2 - Ardito, Luca

A2 - Jedlitschka, Andreas

A2 - Morisio, Maurizio

A2 - Torchiano, Marco

PB - Springer

Y2 - 26 November 2021 through 26 November 2021

ER -

Toivakka H, Granlund T , Poranen T , Zhang Z. Towards RegOps: A DevOps Pipeline for Medical Device Software. In Ardito L, Jedlitschka A, Morisio M, Torchiano M, editors, Product-Focused Software Process Improvement - 22nd International Conference, PROFES 2021, Proceedings. Springer. 2021. p. 290-306. (Lecture Notes in Computer Science). doi: 10.1007/978-3-030-91452-3_20

Towards RegOps: A DevOps Pipeline for Medical Device Software

Abstract

Publication series

Conference

Funding

Keywords

Publication forum classification

ASJC Scopus subject areas

Access to Document

Fingerprint

Cite this