Full Description

This standard operating procedure defines a method for performing, documenting, approving and archiving a medical device risk analysis. This procedure is suitable for all manufactured and distributed medical devices that are used in clinical trials, placed on the market, or put into service. Adheres to Medical Device Directive, ANSI/AAMI/ISO 14871:2000, Application of Risk Management to Medical Devices, and IEC 60601-1-4, Medical Electrical Equipment. Attachments include Example of Risk Graph, Risk Analysis Table, and flow chart of risk control process.

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Edition: 1 Published: 01/01/2005 Number of Pages: 8