If SDDH‑011 is a drug/medical device, include:
| Risk Category | Description | Likelihood | Impact | Mitigation | |---------------|-------------|------------|--------|------------| | | (e.g., sensor drift, software bug) | – | – | – | | Safety / Toxicology | (e.g., adverse events, material hazards) | – | – | – | | Regulatory Non‑compliance | – | – | – | – | | Supply‑Chain Vulnerability | – | – | – | – | | Intellectual‑Property Risks | Patent infringement, freedom‑to‑operate | – | – | – | sddh-011
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