Building the Right QMS at the Right Time: A Practical Guide for MedTech Startups

Most MedTech startups don’t implement a QMS too early… They implement it too late.

By the time teams realize they need one, they’re already scrambling to recreate documentation, fill traceability gaps, prepare for audits, or support a regulatory submission.

The good…

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Thanks so much @quickvault-by-veeva – this is an incredibly informative article!

Did you know that cybersecurity is now a QMS requirement in the US?

If your cybersecurity documentation lives in a folder outside your QMS, it may be time to rethink your process.

In our latest article, Christian from Blue Goat Cyber and Axel from the QuickVault team break down the documentation MedTech companies need to create, control,…

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One week left until our webinar on How Industrial Design Drives MedTech Adoption & Commercial Success! Register now to secure your spot for a webinar with QuickVault by Veeva and Cortex Design on June 25 at 11AM ET.

“Safe and effective” is the baseline. However, the MedTech products that succeed in the market are also intuitive, trusted by…

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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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Hi Holly, yes! Everyone who registers will get access to the on-demand recording and free resources!

Registered and looking forward to attending! I may be driving – if I can’t catch it all, will we get a recording after?

For many MedTech professionals, understanding regulatory requirements can feel like the biggest hurdle to getting to market.

But what if you could use regulatory knowledge as your competitive advantage?

Join us March 26 for a free webinar led by QuickVault by Veeva and Qserve Group to learn how you can leverage early regulatory education to…

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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

Yeah hey Jude, seems like these guys have you in good shape, but there is an eSubmitter software you can download and after that you should he able to directly access the gateway from your desktop. But once inside, you can select the option for FDA form 3500A.

If you also need help with assigning any of the codes associated with any MDR, let…

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For those who’ve moved from a manual QMS to an eQMS:

What was the tipping point?

Audit readiness? Team growth? Regulatory pressure?

Sharing a visual comparison we made that looks at the main differences between the two. We would love to hear what pushed your team to modernize this system (or why you haven’t yet).

Hi Jude, happy to help as well. Here is a link to the FDA’s page for the ESG NextGen:

https://www.fda.gov/industry/electronic-submissions-gateway-next-generation-esg-nextgen/getting-started-esg-nextgen

If you have additional questions or want further pointers, please reach out directly.

Hi Grace. I may be able to help you out. If you are open to an initial discussion, please reach out to me at mdehass@medicept.com or at (717) 476-0702.

Kind regards,

Melissa

Hi Jude. Yes, I can help you out – let’s connect directly!