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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.

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

  1. 1. They forced you to make documentation… save yourself with automated compliance Vlad Știrbu CompliancePal 10.12.2019 @VladStirbu @CompliancePal
  2. 2. Who am I? Vlad Știrbu ● CompliancePal ● Nokia ● PhD Computer Science
  3. 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. 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. 5. Modern agile
  6. 6. “Documentation is not real work.” (not to be named) Lead Front-End Developer CompliancePal@VladStirbu @CompliancePal
  7. 7. Conformance Best Medical Product v1.0 CompliancePal
  8. 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. 9. ISO 62304: Medical software development life cycle CompliancePal
  10. 10. Modern agile meets regulated environments CompliancePal Requirements Wikis Commits Configurations Tests Containers Deployments
  11. 11. Modern agile meets regulated environments CompliancePal Requirements Wikis Commits Configurations Tests Containers Deployments developers designers architects management system administrators end-users auditors
  12. 12. https://twitter.com/rsiilasmaa/status/849940433358778369 CompliancePal
  13. 13. Reality of agile meets regulated environments CompliancePal
  14. 14. GitHub flow CompliancePal
  15. 15. Augmenting GitHub flow for developers CompliancePal
  16. 16. Augmenting GitHub flow for compliance officers CompliancePal
  17. 17. Continuous seamless experience Git CompliancePal Developer/ Architect Compliance Officer commit notification status Team chat problems view Backlog compliance issues status CompliancePal
  18. 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. 19. vlad@compliancepal.eu https://compliancepal.eu @VladStirbu @CompliancePal

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