EU
The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
EU
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
EU
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
EU
The new article elaborates further on the aspects related to risk management in the context of medical devices to be used in the course of clinical investigations.
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