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A new approach for medical device product documentation
Mid Sweden University, Faculty of Science, Technology and Media, Department of Information Systems and Technology.
2017 (English)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesis
Abstract [en]

Hardware and software developers rely on different tools for document management,

product data management (PDM) and software configuration management

(SCM). As more and more products include components of both types

there is a growing demand for one collaborative system. This becomes even

more critical in the medical sector, where a device is under regulatory demands

for document management to even be allowed in to the market. Combined systems

become more complex and are generally based on PDM-principles rather

than SCM. Current development of SCM tends instead towards simpler systems

focused on pure version control (VCS) that are easy to use and economically

available to small- and medium sized enterprises (SME), which is not the case

with generic PDM-systems or combined systems.

This study explored the possibility to extend the usage of such a VCS and include

hardware documentation as well as software. The aim was to further our

understanding of the SME perspective on product documentation for the medical

device field. The method was a case study, collaboration with a SME development

company. The scope was to explore possible usage of a chosen VCS

(GitLab) and to compare it with a generic PDM-system and with existing manual

system.

The results showed that for several of the hardware document types there are

special made Git-solutions to find within the open source community. However,

none of the ones tested in the study was deemed good enough with respect to

functionality and reliability. Instead the case study used direct storage of the

files in their binary format and focused on testing different VCS functions and

on how to organize in order to best gain the advantages of using the system.

The conclusions showed that hardware documents can be stored in the same

iterative manner as software but with limited Git functionality. Compared with

a PDM system GitLab can offer the same level of revision control and communication

around the specifications but lacks classification of parts and detailed

product structures. GitLab offers better iteration history than both a PDMsystem

and the existing manual system does. But not being able to use full Git

functionality the organization needs a collaboration strategy to handle the decentralized

storage. If the collaboration strategy matches the organization development

practices, GitLab is a useful alternative for medical device documentation.

Place, publisher, year, edition, pages
2017. , p. 37
Keywords [en]
Medical device product documentation, PDM, CSM, VCS, SME, Git, GitLab
National Category
Computer Sciences
Identifiers
URN: urn:nbn:se:miun:diva-31055OAI: oai:DiVA.org:miun-31055DiVA, id: diva2:1117449
Subject / course
Computer and System Sciences
Supervisors
Examiners
Available from: 2017-06-29 Created: 2017-06-29 Last updated: 2018-01-13Bibliographically approved

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CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf