BfArM
The new article addresses the matters related to interoperability for medical software products.
BfArM
The article addresses the aspects related to data protection in the context of digital health applications.
BfArM
The new article provides an overview of the general requirements to be followed when filing submissions associated with digital health applications.
BfArM
The new article highlights the aspects related to the temporary and permanent admission of digital health applications. Table of Contents The German regulating authority in the sphere of healthcare products, the Federal Institute for Drugs and Medical Devices...
CDRH
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
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