Nov 15, 2023
FDA
The article highlights the aspects related to certain specific hazards associated with the use of medical devices in the magnetic resonance environment – namely, displacement force and torque.
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Nov 15, 2023
FDA
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.
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Nov 3, 2023
FDA
The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.
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Nov 3, 2023
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
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Nov 2, 2023
FDA
The article highlights the key points related to the application process and outlines the most important aspects to be taken into consideration by applicants.
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