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Medical devices - Application of risk management to medical devices


Document Number: ISO 14971:2007
File Size: 1.4 MB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $259.00
Product Details

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

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