Medical device software the devops way
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The document discusses the integration of DevOps practices in the development of medical device software, emphasizing the balance between agile methodologies and regulatory compliance. It highlights the roles of compliance officers and software developers, outlining their responsibilities in maintaining regulations and quality standards in a regulated environment. The document also addresses challenges and solutions related to documentation, tooling, and workflow management in medical software development.
Medical device software the devops way
- 1. Medical device software the devops way Vlad Știrbu Health Engineering Finland 26.09.2019 Helsinki
- 2. 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
- 3. 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
- 6. IEC 62304: Development processes and activities CompliancePal
- 7. Modern agile meets regulated environments CompliancePal Requirements Wikis Commits Configurations Tests Containers Deployments
- 8. Faux agile meets regulated environments CompliancePal
- 9. CompliancePal “Documentation is not real work.” (not to be named) Lead Front-End Developer
- 10. CompliancePal Photo by Jeffrey Coolidge/Iconica/Getty Images
- 11. Automated medical software compliance CompliancePal Compliance Officers ➔ Take care of regulations ➔ FDA, MDR ➔ ISO 14971, ISO 13845, ISO 62304 Software Developers ➔ Develop software ➔ Maintain cadence Tooling ➔ Chores and bookkeeping ➔ Enforces workflows ➔ Acts as quality gatekeeper ➔ Traceability ➔ Generates reports on demand
- 12. Seamless experience Git CompliancePal Developer/ Architect Compliance Officer commit notification status Team chat problems view Backlog compliance issues status CompliancePal
- 13. Demo
- 15. Compliance activities in sync with development
- 16. Move as agile, act as regulated