Dear Marcelo, Ah yes! We would (of course!) "establish, implement, and maintain" that procedure, too. For us, that goes without saying, but I...
Dear Marcelo, Many thanks for the quick reply and for the insight in what the standard writers were thinking when revising ISO 13485. I can see...
Dear Colleagues, The second paragraph of section 7.1 of the standard has a rather odd requirement in it. It says we have to “document one or...
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