Holly
Forum Replies Created
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Registered and looking forward to attending! I may be driving – if I can’t catch it all, will we get a recording after?
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A few things:
– Cost to pay someone to do some of the work thats automated in an eQMS
– Audit findings that could be better addressed through an electronic QMS
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Hey Greg! I am wondering if you are potentially getting some requests through the Blueprint Program, which I am supporting… lets chat more!
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Hi Ash, also not sure if you intended to include any type of screenshot or anything but what specifically in the IFU were they pushing back on? Thanks!
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Thank you! The general consensus seems that its incredibly de-regulating. Normally I think we would all applause at that but it may sway into a potentially dangerous zone. Will be interesting to see how some key players respond next.
For anyone working with wellness or borderline wellness devices, what’s your next step? I have one so now I am feeling like we have to rethink all of our latest guidance to them…
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Thanks this is wonderful! I would be interested to see how @quickvault-by-veeva compares?
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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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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 same language.
Curious to see how others are handling their transition plan!
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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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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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Hi Nick! I have someone who may be able to help – feel free to direct message me and I can make the connection!
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That would be great, thanks Jude!
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@jshellito what are your thoughts on creating a terminology “map” so that manufacturers don’t have to overhaul as much?
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It does, thanks so much Joe!
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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)?
