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.
HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
BfArM
The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.
EDA
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
Swissmedic
The article provides an overview of the trend report template issued by the Swiss regulating authority.
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