Exclusive - Iec 62304 Checklist Xls

Organize your rows into these six core lifecycle processes as suggested by Qualio and Signify : 1. Software Development Planning (Clause 5.1)

20, 9.2, "Identification of hazardous situations from software", Risk, "Document hazards contributed by software and risk acceptability", "Hazard log, FMEA/FMECA", "Hazards analyzed and mitigations assigned", Not Started, Safety Engineer, , , High, Iec 62304 Checklist Xls

13, 7.1, "Software maintenance process", Maintenance, "Plan and implement maintenance activities including problem resolution and change control", "Maintenance plan, change control procedure", "Issues tracked; changes controlled", Not Started, Maintenance Lead, , , Medium, Organize your rows into these six core lifecycle

To achieve compliance with , medical device software teams often use Excel (.xls) checklists to track the high volume of documentation and process requirements. These checklists serve as a gap analysis tool and a roadmap for auditors. Core Components of an IEC 62304 XLS Checklist Core Components of an IEC 62304 XLS Checklist

In the first tab of her Excel file, Sarah listed the "Rules of the Road." Development Plan : Does a document exist defining the milestones? System Requirements : Are the user needs translated into technical "shalls"? Traceability

| Clause | Activity | Class A | Class B | Class C | Status | Reference to ISO 14971 | Date | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | | Identify hazardous situations | ✔ | ✔ | ✔ | | Hazard log | | | 6.1 | Risk control measures in software | ✔ | ✔ | ✔ | | Risk control spec | | | 6.2 | Verify risk controls | ✔ | ✔ | ✔ | | Verification report | | | 6.3 | Risk management of software changes | ✔ | ✔ | ✔ | | Change impact analysis | | | 6.4 | Residual risk evaluation | ✔ | ✔ | ✔ | | Residual risk report | | | 6.5 | Risk-benefit analysis (if needed) | ✘ | ✔ | ✔ | | Risk-benefit doc | |