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- Tag: hazard-analysis
Tag: "hazard-analysis"
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Hazard analysis is the must-have risk management approach in medical device industry. While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests b...
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Medical device risk management isn’t just another regulatory checkbox. It’s the foundation that proves your device is safe for patients and users. When auditors come knocking, they’ll scrutinize your...
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In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact pati...
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Hazard analysis is crucial in safety-critical product development, especially for medical devices. You can conduct hazard analysis also in Jira - check out the guide below. If you prefer to watch the...
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Your medical device software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Un...
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