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Thanks Marcelo for your time and expertise
The auditor first approach to our TF off site review was to state that it was not a medical device and to stop the audit right there. Because the intended use did not fit the Directive definition. Fortunately I remembered that a CAPA was opened on the first submission of the TF, regarding device classification, to the notified body that mentioned a Consensus Statement that it was indeed a medical device, from here the 28 pages CAPA ensued.
Thanks for this:
If electrical safety requirements would be expected, that standard would have mentioned and required compliance with IEC 60601. It does not.
I will use it. Can you provide any example where a product standard clearly mentions 60601 compliance?
In order to strengthen the argument
The auditor first approach to our TF off site review was to state that it was not a medical device and to stop the audit right there. Because the intended use did not fit the Directive definition. Fortunately I remembered that a CAPA was opened on the first submission of the TF, regarding device classification, to the notified body that mentioned a Consensus Statement that it was indeed a medical device, from here the 28 pages CAPA ensued.
Thanks for this:
If electrical safety requirements would be expected, that standard would have mentioned and required compliance with IEC 60601. It does not.
I will use it. Can you provide any example where a product standard clearly mentions 60601 compliance?
In order to strengthen the argument