Agile Successes in Regulated Medical Development
summary
Case studies show agile practices delivering auditable, regulator-friendly outcomes: OpenClinica wires BDD with Cucumber and Gherkin into Jira to generate executable tests, a traceability matrix, automated permutations, better story estimates, and retrospectives that feed CAPA, enabling continuous releases for clinical-trial workflows. A Cornwall embedded firm uses TDD and pair programming, blind hiring and a bottom-up QMS, grows ~50% yearly to ~70 people with ~4% turnover, declines formal certification by letting clients hold ISO responsibility, and successfully rewrites risky legacy code.
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chapters (21)
- 0:00Introduction
- 0:45Who are Brian and Nancy
- 4:10Working from first principle
- 4:32Our book
- 4:51What prompted the book
- 7:09Examples
- 8:42Clinical Trials
- 10:17Planning
- 12:50Continuous Improvement
- 15:08Summary
- 15:34Leading Through Quality
- 15:46About Bluefruit Software
- 17:09What are certifications
- 19:02Quality management system
- 22:22Empowerment
- 23:03Backstory
- 24:51Explanation
- 29:45Surprise Benefits
- 32:11Quality and Empowerment
- 33:11Agile Principles
- 38:02User Stories
