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.

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

2. Who am I?
Vlad Știrbu
● CompliancePal
● Nokia
● PhD Computer Science

3. 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

4. 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

5. Modern agile

6. “Documentation is not real work.”
(not to be named) Lead Front-End Developer
CompliancePal@VladStirbu @CompliancePal

7. Conformance
Best
Medical
Product
v1.0
CompliancePal

8. 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

9. ISO 62304: Medical software development life cycle
CompliancePal

10. Modern agile meets regulated environments
CompliancePal
Requirements
Wikis
Commits
Configurations
Tests
Containers
Deployments

11. Modern agile meets regulated environments
CompliancePal
Requirements
Wikis
Commits
Configurations
Tests
Containers
Deployments
developers
designers
architects
management
system administrators
end-users
auditors

12. https://twitter.com/rsiilasmaa/status/849940433358778369
CompliancePal

13. Reality of agile meets regulated environments
CompliancePal

14. GitHub flow
CompliancePal

15. Augmenting GitHub flow for developers
CompliancePal

16. Augmenting GitHub flow for compliance officers
CompliancePal

17. Continuous seamless experience
Git CompliancePal
Developer/
Architect
Compliance
Officer
commit
notification
status
Team chat
problems
view
Backlog
compliance issues
status
CompliancePal

18. 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

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