Holly
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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 4 months ago
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Elaine and
Holly are now connected 5 months 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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