Tag: FDA
Tipps Zum FDA Guide “Interoperable medical devices”
Die FDA The importance of medical devices’ abuse recognized at the beginning and 2017 Dokument Guida ‚Interoperable medical devices’ Published. The American authority would like to take into account the fact that the interoperability of medical devices is important for health care on the one hand. On the other hand, problems with a lack of…
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The FDA eStar Program: Obligation or Opportunity?
With the eStar program The FDA wants to increase the efficiency of approval processes (e.g. the 510(k) process) through digitalization. The Johner Institute is working with the FDA to further develop eStar. In this article you will find out how far-sighted this approach is and whether you should or even need to take part in…
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