The scanned electronic signature is acceptable to kept as electronic record? example, the report has needed to be signed by 3 approvers. 1st...
I am new to testing the ECG device as per IEC 60601-2-25 standard. I want to test a battery operated ECG device, which can work in 6 lead or 12...
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...
Our client, a leader in medical device instruments and implants, is growing their team and seeking an experienced Quality Engineer to help with...
"Today the FDA published a Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a...
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf?source=govdelivery&utm_m...
"Today the FDA opened a docket for public comment titled, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing...
The release follows a review of adverse events reported between 2009-2016....
Hello everyone, 21 CFR 820.20 (d) "Quality planning" requires a quality plan to ensure quality requirements. Since we (a German OEM) follow...
Is there a regulatory requirement (either ISO 13485 or FDA CFR) to have a written SOP/work instruction for each piece of laboratory equipment,...
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHVisionandMission/UCM481588.pdf?source=govdelivery&u...
Wondering what the recommended pressure unit for US public is (specifically when labeling operational, transport and storage conditions)? I've...
Hi Everyone, Just curious: has anyone (successfully) attempted to push-back against an FDA observation that items in one of their guidance...
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...
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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