Holly
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Holly and
Nicholas are now connected 3 weeks ago -
Manufacturing and Import Authorization - UK
Hi everyone – I have a combo product question for ya. Does anyone know what all is required for a UK manufacturing and import authorization of investigational medicinal products if the manufacturer is located in the US? The guidance is a bit confusing as it seems to only focus on manufacturers located in “approved countries” which, as far as I…
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Reply to Upcoming Webinar 3/26: How MedTech Knowledge Drives Startup Success
Registered and looking forward to attending! I may be driving – if I can’t catch it all, will we get a recording after?
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A few things:
– Cost to pay someone to do some of the work thats automated in an eQMS
– Audit findings that could be better addressed through an electronic QMS
QuickVault -
US IVD Consultants with Availability?
Hi everyone, I have a potential contract for a preliminary regulatory strategy of a startup IVD company. If interested in 1099-ing with me, please reach out!
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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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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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Welcome & FDA's Updated Compliance Program
First, WELCOME to so many of our newest members! It is so exciting to see both new and familiar faces!
Second, has anyone had a chance to really digest the updated FDA compliance program? Would love a quick briefing on key changes/updates! Thank you all in advance!
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Jeff and
Holly are now connected 3 months ago -
Hi everyone! FutureReady: MedTech Live is back with Episode 04: QMSR – The Eleventh Hour. Join us, along with an esteemed panel, on Thursday, January 29 at 4 pm EST to discuss everything QMSR and what you can do now to be (more) ready on February 2.
Register here: …
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