An easy to use, semi-automated tool to help you comply with ISO 14971:2019 and make a bridge with post-market surveillance.
✔️ This Excel file allows you to document your entire risk analysis.
✔️ It automatically calculates the critical number (Occurrence x Severity) and the risk priority number (Occurrence x Severity x Detectability) for each risk.
✔️ All of the formulas and the layout will make it easier for you to format your risk analysis.