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Malte Noel Schmidt

Global Portfolio Manager for Medical Device Software, AI, and Cybersecurity at TÜV SÜD, a notified body supporting MedTech startups with regulatory strategy and market access.

Jul 27, 2026

7:56
Yeah
7:56
... that you need to cross.
7:57
So the question we asked ourselves, and something that I also try to investigate a little bit more, did some research on, how can you, how can you build a path towards that CE certification or that FDA approval or whatever market you wanna go to first that sort of leave bread crum- crumbs, that leave steps that show that your company actually has regulatory maturity, that it's not something that is ...
8:23
It's not just the, the certificate or the approval that is relevant, but it's also like, have you hired people that know what they are talking about? Have you hired quality people? Have you hired regulatory people? Or are you working with consultants? Or how, how do you, how do you sort of fill that void? Have you, for example, started working with a QMS? Like, even if that's, even if you have not had full certification or a partial certification of that QMS, like are you already working towards building a quality management system? Because that shows that you're sort of building yourself or building rules for yourself that in- start to ensure that y- that you're building a medical device that you know that you're not ...
9:04
You're in a different game.
9:05
You're not building an e-commerce platform.
9:07
I worked in quite some startups where a lot of people came from the e-commerce side, for example, and the assumption was like, "Yeah, let's build, measure, learn.

16 MINS LATER

25:45
And if, and maybe, maybe backing up upstream of that, what are the goals with leaving the ivory tower? And if you wanna speak just a little bit more to that, because I am curious more to hear about that.

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