Risk Management Specialist
alirezarezvani/claude-skillsA medical device risk management specialist follows the ISO 14971 standard to keep people safe. This tool helps find possible hazards and problems with medical devices. It guides you through risk analysis, risk evaluation, and risk control steps.
Anyone involved in medical device safety can use this tool. It covers FMEA, fault tree analysis, and benefit-risk analysis. The skill also handles risk monitoring after the device is sold and updates to the risk management file.
The built-in risk matrix and decision frameworks make it easy to decide if a risk is acceptable. For EU MDR devices, it reminds you to reduce risks as far as possible without thinking about cost.
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