The purpose of this IMDRF guidance is to harmonize the documentation and procedures that are 60 used to assess whether a medical device conforms to the regulations that apply in each jurisdiction. The worldwide adoption of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.
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