Hi guys, a question recently came up relating to DMRs. Does anyone have any clarification on what is specifically meant by "(E) Installation,...
Hello! I am looking for some input on the idea of a "catch up" 510k. When you have made several minor changes that only required a letter to...
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf?source=govdelivery&utm_m...
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, 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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