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Elaine joined the group
indieFeed 5 months ago -
Jenn joined the group
indieFeed 5 months ago -
Holly posted an update in the group
indieFeed 5 months agoThe U.S. federal government is now in a shutdown, effective October 1, 2025. Below is what the MedTech community should know — and how to keep perspective through the disruption. Good news? Most of the existing MedTech review work is funded by user fees, and as a result, the FDA has a bit of cushion to continue their critical work even during…
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Anchal joined the group
indieFeed 5 months ago -
Mo joined the group
indieFeed 5 months ago -
Holly posted an update in the group
indieFeed 6 months agoJust released – a DRAFT MDCG on Questions and Answers on Trend Reporting as Outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics medical devices: https://ec.europa.eu/transparency/expert-groups-register/core/api/front/document/121204/download
Excited to see this as I think this…
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Hi Holly – I have not been involved with this one. I tried to have a link, but I don’t seem to be able to download from the link provided, and I can’t find it on the main europa site (I know it’s there. I just can’t find it! 🙂 )
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Holly posted an update in the group
indieFeed 6 months agoWHO IS READY FOR RAPS CONVERGENCE 2025?! It is only three weeks away and I am getting VERY excited for some things were planning… here is a sneak peak
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Nicholas started the discussion Now hiring at MEDIcept – Sr. Regulatory Consultant in the forum IndieMedTech 6 months ago
Now hiring at MEDIcept - Sr. Regulatory Consultant
Hi Everyone,
In case you haven’t heard of MEDIcept, we are a small Consultancy and CRO for the Medical Device Industry. Due to popular demand of SaMD and SiMD experience, our Regulatory team is growing! It is a salaried position with benefits. Please reach out if you would like to learn more! nradoux@medicept.com
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Purvi joined the group
indieFeed 6 months ago -
Holly replied to the discussion ISO 10993-1:2025 in the forum IndieMedTech 6 months ago
I have also been hoping for some more information on this and guidance on how to raise this with clients so we can adequately anticipate any impact to testing strategies?
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