Thank you, Ronen!
Hello everyone, 21 CFR 820.20 (d) "Quality planning" requires a quality plan to ensure quality requirements. Since we (a German OEM) follow...
Hello everybody, our customer wants to export our microarray scanner, which is an IVD, to the US. They state, that for the approval process the...
This one helps a lot! Thanks!
Thanks for the quick answer, Ronen! Furthermore, I was wondering, since GMP is a law and ISO 9001/13485 is a "benefical" certification, where is...
Hello everybody, we are a German OEM for medical devices. One of our customer will have the US as a new target market. So we need to comply with...
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