BfArM
The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products.
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
HPRA
The new article addresses the matters related to medical devices and associated fees.
FDA
The article provides an overview of the regulatory requirements related to safety in the magnetic resonance environment and highlights the key points to be taken into consideration by medical device manufacturers and other parties involved.
BfArM
The new article addresses the matters related to interoperability for medical software products.
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.
