EDA
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
FDA
The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.
Swissmedic
The article provides an overview of the trend report template issued by the Swiss regulating authority.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
EDA
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
