Medical devices
Agile and traceable on medical device software
- NeedTicket: type, acceptance criteria, target version
- CodeCommit linked to the ticket, description checked against the merged code
- VerificationBy someone other than the developer, test label checked
- ValidationRegression testing and V&V report for the release
- ReleaseDecision recorded in the validation ticket
- DocumentationRelease notes and user manual Anomaly
FeedbackAnomaly, customer complaint, device vigilance, CAPA, exchanges with the ANSM: a new ticket
checked automaticallygenerated automaticallydecided by the team
StandardsIEC 62304ISO 13485MDR









