Photo: Forms with stamps around

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Special February 2015

Norms and standards internationally - safety versus restrictions?

In medical technology it can be fatal if a device is not working properly. There are various testing and approval procedures in order to ensure its safety and function. International standards like the ISO norms are one of the bases for this. Their implementation is not the same everywhere in the world because some countries add their own individual regulations. For manufacturers this means more effort in the approval of a device, for doctors and patients on the other hand more time they have to wait for it. Read how approvals could be optimized internationally in the future in the current COMPAMED Special.