Risk Management: EN ISO 14971
The medical device directives as well as different standards applied in the context of the directives require a risk management procedure. EN ISO 14971 describes a process for the application of risk management for medical devices. The standard offers a procedure which enables the manufacturer to identify, assess, and control the risks linked to its medical device.
EN ISO 14971 is applicable to all medical devices and to the entire life cycle of the device. This includes development and manufacturing just as application, use and disposal.
The standard is harmonized with all three directives concerning medical devices. Its application therefore justifies the assumption that the product fulfils the respective requirements set out in the directives.
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"EN ISO 14971: a standard linked closer to other standards than any other. Give it the attention it deserves!"