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Anchal joined the group
indieFeed 2 months ago -
Mo joined the group
indieFeed 2 months ago -
Holly posted an update in the group
indieFeed 2 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 2 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 2 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 2 months ago -
Holly replied to the discussion ISO 10993-1:2025 in the forum IndieMedTech 2 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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Daria started the discussion ISO 10993-1:2025 in the forum IndieMedTech 2 months ago
I see that ISO 10993-1: 2025 is under publication and will be releasing soon, and that the US voted “NO” for the changes. I can’t find any intel about what specific clauses the US objected to other than “cumulative use” (how repeated uses of a device add up in exposure) which will significantly revise (increase) the contact duration and…
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Garrett joined the group
indieFeed 2 months ago -
Holly posted an update in the group
indieFeed 2 months agoDid anyone see this? Zimmer Biomet sues Deloitte over disaster implementation of an enterprise resource planning software for $172M – this is pretty wild to see such a huge lawsuit over essentially ineffective consulting support. Will be interested to see how this plays out.
Link here: https://www.massdevice.com/zimmer-biomet-sues-deloitte-for-172-million/
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I did, I read an article about how consulting firms have promised a great deal regarding AI and then have provided little to no results. Although the Deloitte issue was an ERP system. I think the principle is the same overpromising and underdelivering. In the end I think the lawsuit will be dropped for additional support. But we will…
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Overpromising and underdelivering – the key!
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