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

1. My Tuleap Story #TuleapCon2017 @TuleapOpenALM
100 % Agile & Open Source
Nicolas Gaiffe
Software Development Manager
Sleepinnov Technology
@nclsgffnicolas.gaiffe@sleepinnov.com

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100 % Agile & Open Source
My Tuleap Story
Context
• Medical Devices
• Small company (9 employees)
• Small software development team (4 engineers)
• Growing

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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

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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

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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

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100 % Agile & Open Source
My Tuleap Story
Knowledge transfer
• Documents
• Mediawiki
Planning
• Trackers
• Agile Dashboard

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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

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100 % Agile & Open Source
My Tuleap Story
Custom quality insurance trackers

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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)

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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

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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

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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

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100 % Agile & Open Source
My Tuleap Story
Thank you for listening
and
A huge thanks to all Tuleap contributors