They Forced You to Make Documentation. Save Yourself with Automated Compliance

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In his talk Vlad explains the lifecycle of medical softwares, how modern agile meets regulated environments, and what to keep in mind when you document such softwares and APIs.

Technologie

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

“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 CE 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

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 real use of the documentation
Do it for real, not by obligation

vlad@compliancepal.eu
https://compliancepal.eu
@VladStirbu @CompliancePal

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They Forced You to Make Documentation. Save Yourself with Automated Compliance

1. They forced you to make documentation… save yourself with automated compliance Vlad Știrbu CompliancePal 10.12.2019 @VladStirbu @CompliancePal

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They Forced You to Make Documentation. Save Yourself with Automated Compliance