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Risk Management for Medical Devices
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Item Number: NWRR0502
A procedure that describes a framework for effective risk management and the integration of risk management concepts into the quality system. The procedure includes: elements of a risk management system; elements of a risk management plan; determination of risk acceptability criteria; risk management during design and development; risk management and product traceability; and risk management for purchasing controls, production and process controls, servicing, CAPA, and statistical techniques. This 24-page document, including three attachments [Questions to Identify Medical Device Characteristics (Example), Sources of Possible Hazards (Example), and Risk Management Summary Table (Example)], applies to all medical devices and their accessories designed, developed, and/or produced by the company. Responsibility is assigned for each step of the procedure.
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