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Ash updated their profile 4 months ago
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Ash updated their profile 4 months ago
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Rob and
Etienne are now connected 4 months ago -
Nivedha joined the group
4 months agoindieFeed 4 months ago -
Reply to IVDR Metrological Traceability
Hey Holly, sorry, I meant the metrological traceability section. No screen shot, we don’t have any verbiage for it yet.
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Reply to IVDR Metrological Traceability
It is a standalone control used to verify calibration of clinical lab equipment. The NB seems to want to see metrological traceability back to the original control material or some statement to that effect in the IFU.
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Reply to Reimbursement Experts?
Hey Greg! I am wondering if you are potentially getting some requests through the Blueprint Program, which I am supporting… lets chat more!
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Hello – my company, Simbex, is a product design and development firm that offers regulatory, reimbursement and market intelligence for medtech companies. We have been inundated with requests for reimbursement support and would love to connect with a reimbursement expert consultant that may be able to support our current team. Feel free to…
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Reply to IVDR Metrological Traceability
Hi Ash, also not sure if you intended to include any type of screenshot or anything but what specifically in the IFU were they pushing back on? Thanks!
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Reply to IVDR Metrological Traceability
Hi Ash can you be more specific as to what on the Medical Device requires Metrological Traceability ?
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