Update the plan regularly, especially for Class C where standards, methods, and tools must be specified.
Software hazard analysis, risk control implementation, and verification of mitigations. Configuration
38, 21.2, "Regression testing for changes", Change Control, "Run regression tests when software changes are introduced", "Regression test suite, results", "No regressions in safety-critical functions", Not Started, Test Lead, , , High,
You must have a formal system for managing bugs, defects, and anomalies found during development or post-market use. Iec 62304 Checklist Xls
The exact section from the IEC 62304 standard (e.g., Clause 5.1.1).
Testing against the final software requirements. Release: Criteria for software versioning and distribution. 2. Risk Management (Clause 7)
The Ultimate IEC 62304 Checklist XLS: Ensuring Medical Device Software Compliance Update the plan regularly, especially for Class C
What are the IEC 62304 Safety Classifications? - Greenlight Guru
: Uniquely identify all source code files, documentation, tools, compilers, and SOUP items.
This module bridges the gap between ISO 14971 (Medical Device Risk Management) and your software lifecycle. The exact section from the IEC 62304 standard (e
To make your checklist actionable, include the following columns in your spreadsheet:
This article is for informational purposes and does not constitute legal or regulatory advice. If you'd like, I can: Suggest in a vendor-provided checklist. Create a sample structure for your own XLS. Explain how to map this to ISO 13485.