BfArM
The article addresses the aspects related to the fees payable by the interested parties and also provides definitions of the most important terms and concepts.
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.
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.
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.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
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