Jude
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My client has the need to set up and begin submitting MDR’s. The guidance mentions an ESG Next Gen gateway. I have never set this up. Does anyone have experience with this and can provide some pointers.
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IVDR Metrological Traceability
Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?
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Jude and
Niki are now connected 3 months ago -
Jude and
Catherine are now connected 3 months ago -
QMSR Transition: Medical Device File vs. DMR/DHF
Hi Holly, I would love to share the definition comparison. I am unable to upload to this site. Any help would be appreciated. TY
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QMSR Transition: Medical Device File vs. DMR/DHF
Hi Holly, I think that would be a valuable tool to help facilitate common understanding of similar terms. I do think the transition to a common 13485 terminology may take years as these terms are well ingrained into corporate culture. Would you like me to put something together ?
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Jude updated their profile 4 months ago
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Elaine and
Jude are now connected 5 months ago - Load More