Hi everyone – I have a combo product question for ya. Does anyone know what all is required for a UK manufacturing and import authorization of investigational medicinal products if the manufacturer is located in the US? The guidance is a bit confusing as it seems to only focus on manufacturers located in “approved countries” which, as far as I…

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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?

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

Hi everyone, I have a potential contract for a preliminary regulatory strategy of a startup IVD company. If interested in 1099-ing with me, please reach out!

Hey Greg! I am wondering if you are potentially getting some requests through the Blueprint Program, which I am supporting… lets chat more!

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!

First, WELCOME to so many of our newest members! It is so exciting to see both new and familiar faces!

Second, has anyone had a chance to really digest the updated FDA compliance program? Would love a quick briefing on key changes/updates! Thank you all in advance!

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…

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FDA dropped two new guidance documents today:

• General Wellness: Policy for Low Risk Devices – https://www.fda.gov/media/90652/download
• Clinical Decision Support Software – https://www.fda.gov/media/109618/download

I haven’t had a chance to dig in yet, but has anyone else? Any significant clarifications or advancements that may tangibly help…

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Hi everyone, I have a client where I am trying to decide whether to recommend a BDDR or a pre-submission first. They will need another pre-submission eventually as their submission requires a GLP animal study and potentially another clinical study (and in their last pre-sub the FDA asked them to present their substantial equivalence table so…

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Thanks this is wonderful! I would be interested to see how @quickvault-by-veeva compares?

I can vouch that @peter-psi and the PSI team are incredible and laser focused on client success!

That would be great, thanks Jude!

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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@jshellito what are your thoughts on creating a terminology “map” so that manufacturers don’t have to overhaul as much?

It does, thanks so much Joe!

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)?

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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Here ya go: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member