Holly
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Does anyone know why we can no longer see 510k summaries in the 510k database? I am even trying old ones that I know I have pulled recently and they are all missing…
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I swear I looked at some this morning and now they are not there. Any updates?
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Not definitively – based on a some folks I have talked to we think its just maintenance things? Fingers crossed – if this was intentional I would hope they would release something about it.
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Holly joined the group
8 weeks agoeQMS 8 weeks ago -
Happy MedTech Monday! We have quite a few new iM members on board from last week – welcome!! Just curious – what is on everyone’s agenda for this week?! Anyone else have a jampacked to-do ahead of Thanksgiving?!
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Happy Monday everyone! I saw this complimentary webinar for this week that I am particularly excited about as I am working through similar justifications currently. Its about leveraging clinical data collected in one region to support regulatory submissions in another region. Thought I would share – its Nov 20 at 10 AM EST!
Link here: …
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Great topic – thanks for sharing Holly!
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I can vouch that @peter-psi and the PSI team are incredible and laser focused on client success!
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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
That would be great, thanks Jude!
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FutureReady: MedTech Live - Episode 01 - Consulting
indieMedTech Community – were partnering with Codon Partners to host our first episode of our new live show FutureReady: Medtech Live, a biweekly show where the MedTech industry can talk openly about what’s working, what’s not, and what’s next.
Why? Because no one navigates the MedTech space alone.
Join us on on November 6 @ 4 pm EST for the…
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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
@jshellito what are your thoughts on creating a terminology “map” so that manufacturers don’t have to overhaul as much?
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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
It does, thanks so much Joe!
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Holly updated their profile 3 months ago
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