Holly
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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 7 weeks 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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Reply to New FDA Guidance Documents
Thank you! The general consensus seems that its incredibly de-regulating. Normally I think we would all applause at that but it may sway into a potentially dangerous zone. Will be interesting to see how some key players respond next.
For anyone working with wellness or borderline wellness devices, what’s your next step? I have one so now I…
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