planB
Super Moderator
Roland,
sorry if I was not clear enough.
Let me quote from the European MDD, Article 2:
"Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose."
This clearly implies that you have to consider operators - and yes, this involves some degree of workload, which to my experience can be limited as I intended to ppoint out previously.
HTH,
Gerhard
sorry if I was not clear enough.
Let me quote from the European MDD, Article 2:
"Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose."
This clearly implies that you have to consider operators - and yes, this involves some degree of workload, which to my experience can be limited as I intended to ppoint out previously.
HTH,
Gerhard