: Because Sarah’s team was building a heart monitor, they marked it as
. Here is how that checklist turned their chaotic "crunch time" into a smooth path to certification. The Foundation: Software Safety Classification Iec 62304 Checklist Xls
| 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 | | : Because Sarah’s team was building a heart
Before checking a single box, you must define your (Class A, B, or C). Your checklist must dynamically adjust, because Class A does not require the extensive documentation that Class C does. Your checklist must dynamically adjust, because Class A
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