Medical device software the devops way

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This is a talk at Health Engineering Finland meetup covering the challenges of using modern agile methodologies for developing medical software. The answer is to how to incorporate activities required by regulations into the #devops activities.

Software

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

Medical Consumer
Reliable
Long-life
Regulated
Hardware
Design
Disposable
Agile
Software
CompliancePal

IEC 62304: Development processes and activities
CompliancePal

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

Faux agile meets regulated environments
CompliancePal

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

CompliancePal
Photo by Jeffrey Coolidge/Iconica/Getty Images

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

Seamless experience
Git CompliancePal
Developer/
Architect
Compliance
Officer
commit
notification
status
Team chat
problems
view
Backlog
compliance issues
status
CompliancePal

Compliance activities
in sync with development

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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

4. Medical Consumer Reliable Long-life Regulated Hardware Design Disposable Agile Software CompliancePal

5. Medical Consumer Reliable Long-life Regulated Hardware Design Disposable Agile Software CompliancePal

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

14. Architecture management SOUP management

15. Compliance activities in sync with development

16. Move as agile, act as regulated

17. vlad@compliancepal.eu