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TuleapCon2017-CaseStudy_Sleepinnov_Medical_Devices

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Tuleap helps achieve medical devices ISO 13485 and IEC/EN 6230. SleepInnov Technology shares they use Tuleap to match demanding medical standards.

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TuleapCon2017-CaseStudy_Sleepinnov_Medical_Devices

  1. 1. My Tuleap Story #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source Nicolas Gaiffe Software Development Manager Sleepinnov Technology @nclsgffnicolas.gaiffe@sleepinnov.com
  2. 2. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Context • Medical Devices • Small company (9 employees) • Small software development team (4 engineers) • Growing
  3. 3. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Challenges Transfer knowledge smoothly Plan next releases Address regulations & standards • CE Marking • ISO 13485 • IEC 62304 > Mandatory compliance > Audited 1+ a year by a notified body
  4. 4. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Configuration 
 1 Tuleap instance • Virtual Machine • Self-hosted 15 Projects : • Commercialized software (embedded, Mobile, PC & web) • Deployment / test applications • General information
  5. 5. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Users All employees have an account Mostly used by • Software Engineers • Support Technician • Quality Manager Not open to outsiders… yet
  6. 6. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Knowledge transfer • Documents • Mediawiki Planning • Trackers • Agile Dashboard
  7. 7. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story ISO 13485 
 Medical Devices – Quality Management Systems • Say what you do • Do what you say • Record what you did • Prove it • Improve it Tools : • Trackers • Documents
  8. 8. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Custom quality insurance trackers
  9. 9. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story IEC/EN 62304 Medical Device – Software Life Cycle Processes Requirements Specifications Acceptance tests Implementation Architecture Unit / Integration tests Functional tests Product Files Git hook for Jenkins Git Trackers Cross-links (traceability)Documents (all layers)Agile Dashboard (planning)
  10. 10. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Benefits User management : • Single authentication for multiple tools • Access-rights tuning at user level Documentation made easy : • Less Office documents ⇒ Focus on content, not layout ! Safety : • No longer able to inadvertently delete valuable data
  11. 11. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Benefits Traceability : • Tracking of every change with date and user name • Almost all info is only one click away
  12. 12. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story What next ? • Better tuning of user access rights inside projects • More Agile Dashboard customization • More Continuous Integration • Code review via pull-requests or Gerrit integration • Look into artefact status (and date ?) “triggers” • Validate Tuleap ! (ISO 13485:2016 § 7.5.6) What’s missing ? • A cross-project Agile Dashboard would be nice
  13. 13. #TuleapCon2017 @TuleapOpenALM 100 % Agile & Open Source My Tuleap Story Thank you for listening and A huge thanks to all Tuleap contributors

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