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They forced you to make documentation…
save yourself with automated compliance
Vlad Știrbu
CompliancePal
10.12.2019
@VladStirbu @CompliancePal
Who am I?
Vlad Știrbu
● CompliancePal
● Nokia
● PhD Computer Science
CompliancePal
Software is eating the world
Marc Andreessen
https://a16z.com/2016/08/20/why-software-is-eating-the-world/
https://earthobservatory.nasa.gov/images/82693/earthrise-revisited
CompliancePal
https://www.dlr.de/dlr/en/Portaldata/1/Resources/bilder/portal/xl_galerie/STS_135_Launch_16_9_xl.jpg
Software intensive products
2015
DevOps
Today
DevOps ++
1970
Waterfall
2001
Agile
Modern agile
“Documentation is not real work.”
(not to be named) Lead Front-End Developer
CompliancePal@VladStirbu @CompliancePal
Conformance
Best
Medical
Product
v1.0
CompliancePal
What does the mark mean?
● Legislation (EU)
○ Medical Device Directive
○ Medical Device Regulation (from 05/2020)
● ISO technical standards
○ 13485 - quality management
○ 14971 - risk management
○ 62304 - software development life cycle
CompliancePal
ISO 62304: Medical software development life cycle
CompliancePal
Modern agile meets regulated environments
CompliancePal
Requirements
Wikis
Commits
Configurations
Tests
Containers
Deployments
Modern agile meets regulated environments
CompliancePal
Requirements
Wikis
Commits
Configurations
Tests
Containers
Deployments
developers
designers
architects
management
system administrators
end-users
auditors
https://twitter.com/rsiilasmaa/status/849940433358778369
CompliancePal
Reality of agile meets regulated environments
CompliancePal
GitHub flow
CompliancePal
Augmenting GitHub flow for developers
CompliancePal
Augmenting GitHub flow for compliance officers
CompliancePal
Continuous seamless experience
Git CompliancePal
Developer/
Architect
Compliance
Officer
commit
notification
status
Team chat
problems
view
Backlog
compliance issues
status
CompliancePal
Start from the beginning
Do it during development with each commit
Find the use of the documentation
Do it for real, not by obligation
vlad@compliancepal.eu
https://compliancepal.eu
@VladStirbu @CompliancePal

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