Martin Witte Presents TUV SUD at LSI USA ‘23

Transcription

Good afternoon. So what I will tell you now about is not asking for your money, I will provide you with some possible solutions to get a medical device on the market quickly, because that's maybe what all of us want to have an innovative and new medical device. I don't the US or the EU or the Asian markets quickly. So who is TUV SUD or s month many of you might know it under TUV to suit is an organization from Germany, which is over 150 years old. And we have 25,000 employees from these 25,000 employees 1500 only work in medical devices and that as a notified body under the EU MDR and as testing services. And the point I wanted to bring over here is the focus on testing services, because on the on the one side we are a notified body. So whenever you have a product that should go to the EU market contact us, it is a myth that there is no capacity and notified bodies, there is capacity. However, it is always important to talk to us early stage. And what is the other topic we are doing is testing. And testing is something that might not be very familiar to everybody when connecting it to TUV SUD. That's why we are here and present to you the solutions we can offer in order to bring those devices on the market quickly. So what we can offer is testing in more or less all relevant aspects biocompatibility microbiological testing, functional safety, electrical safety, also MRI safety, so we have an MRI laboratory set up in Minneapolis, we can do chemical characterization, cybersecurity, we can do professional penetration tests accreditated. We can do EMC testing, and all these electrical safety things and battery testing. Now, why is that important for you? That is important for you because you need evidence in order to convince the FDA or a notified body or any other regulatory agency that your product is safe, and performs as intended. And that's why you want to choose a partner that is reliable, and that has actually tailored laboratories and has experience in this field. And if you face the situation that you don't have capacity with your current partners, for example, in the field of biocompatibility might be a good idea to reach out to us. This is one of the strategic investments we made over the last couple of years and facilities are implemented across the globe. So we also have developments within the US to have biocompatibility testing located in Minneapolis as well. Here, this is something you can read afterwards, because that's death by PowerPoint. I don't want to torture you with that. That's the standards we can test on. And that's what we can provide you microbiology, IQ, environmental packaging, EMC, and all that stuff. But that's nothing I can I will read out to you loud now. Good. Yeah, I think MRI safety is one of the interesting things here. Because MRI safety is one of the topics that came up. Let's say 10 years ago, I've been working in a medical device company doing pacemakers back then, and Medtronic was the very first company brought pacemaker on the market. That was MR Conditional. I was working in a German company being a competitor of Medtronic. And we were facing this problem of how to show that a device like a pacemaker is actually safe in an MRI environment. Up until now, certain development happened. And here we have the lucky situation that we have actually a laboratory set up in Minneapolis doing all the ASTM standards that are listed on this slide, which will be requested by the FDA when you have an implant or something else that you claim is MRI safe or MR Conditional. MRI is also a very special testing. Worldwide there is only four laboratories being able to do this and will become more and more important in future. Yeah, that's more or less it. I'm pretty quick here. But the metrics I wanted to convey is if you want a notified body, come to us if you need services like testing services also come to us and the earlier you come to us the better because we You can offer testing from the prototype stage up until the final validation testing of your device Thank you.