meddev-change-control
Define controlled change-request workflow for software: impact analysis, approvals, verification scope, and regulatory submission flags. Configuration identification and baselines are in DOC-SCM (IEC 62304 Clause 8.1, 8.3); approved implementation and re-verification align with 8.2. Use when working on change control in medical device software.
- Version
- 1.1.0
- License
- MIT
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