Holly
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Holly updated their profile a week ago
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Elaine and
Holly are now connected a week ago -
The 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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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
Hi Joe – quick question, are you remediating anything old, or just plan to implement the new language moving forward (and I suppose for up-revs of existing documentation)?
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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
I imagine it will depend on the stage of a manufacturer – if it is a startup, I think it would make most sense to adopt the 13485 language. For existing manufacturers with robust quality systems and many documents, I imagine that it will be handled procedurally, where the glossary will map the terminology but they will continue to use the…
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Reply to Malaysia is now a MDSAP member
portal.mda.gov.my
MALAYSIA IS NOW A MEMBER OF MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)
Official portal of MDA Malaysia. Regulatory information, device registration & safety under Medical Device Acts 737 & 738
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Holly created the group
5 weeks agoFDA 5 weeks ago -
Holly created the group
5 weeks agoQuality 5 weeks ago -
Just 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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WHO 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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