Weronika Michaluk 0:00
Hi, I'm Weronika, and I'm Principal and software as medical device Practice Lead at HDD health. And at HDD health, we specialize in software as medical device design and development, so we can support companies from product ideation all the way to product market launch. So HTD health, we specialize in software as medical device design and development, and also in non medical software development. So what is important to mention is that we specialize only in healthcare software, and we support organizations from single entrepreneurs, from startups all the way to venture studios, medical centers, universities, research institutions, as well as big organizations like Smith and Nephew, Takeda Pharmaceuticals or Johnson and Johnson. And what we do, we can support different sizes of organization, from product ideation through design development, human factors, usability engineering, all the way to actually design verification, design validation and then successful product launch. As we bring lots of great experts that can help you know entrepreneurs with technology strategy, with business strategy, can help design and develop, not only intuitive software, but also very safe one, because we have to remember that then at the end of this, you know, journey, there is a patient that will be using our software. But we also hold very important certification. We are ISO 13, 485, certified. We also hold ISO 2701 27 Oh 18 certificates when we support our customers, we always value, you know, open, communication, transparency. We really care about our mutual values as we don't want to be just like another vendor that will just do the project and the relationship. We want to be your partner. We want to be your technology partner that will help you grow, that will help you get to this next stage. But another thing is that we bring you know different experts, so it's not only software engineers or designers, but also behavior change, design researchers, human factors, engineering experts, regulatory quality, usability engineering, all these experts come and create one project. If you need support from medical doctors, we have them on board as well. MDs, PhDs are part of our our organization, and thanks to that, we really bring on, you know, so many different perspectives to actually, then create diverse and successful team for our customers. You know, the future is bright. I always say the future is bright because we are expanding our footprint. So we are a global company. We are currently in US and in Europe, and we support so many different great partners, great organizations, and we want to touch, you know, lives of 10 billion patients by 2030 which is very doable for us, because we really work together with many organizations that have a great footprint. So you know, I just want to say that we will continue growing. We'll continue expanding our services and our expertise and just looking forward to the bright future. You.
As the Digital Health Principal and SaMD Lead at HTD Health, I leverage an extensive background in biomedical engineering, international business, and public health to spearhead the delivery of cutting-edge Software as a Medical Device (SaMD) solutions for the healthcare industry. I direct a high-caliber team of engineers and developers, taking a hands-on approach to the entire lifecycle of SaMD products—from concept to deployment. I am committed to meet and exceed regulatory standards, achieve customer satisfaction, and most importantly, ensure patient safety. My commitment goes beyond compliance; it extends to ensuring customer satisfaction and patient safety. I am passionate about harnessing technology to make real differences in healthcare, and this dedication is the cornerstone of my leadership in the SaMD space.
As the Digital Health Principal and SaMD Lead at HTD Health, I leverage an extensive background in biomedical engineering, international business, and public health to spearhead the delivery of cutting-edge Software as a Medical Device (SaMD) solutions for the healthcare industry. I direct a high-caliber team of engineers and developers, taking a hands-on approach to the entire lifecycle of SaMD products—from concept to deployment. I am committed to meet and exceed regulatory standards, achieve customer satisfaction, and most importantly, ensure patient safety. My commitment goes beyond compliance; it extends to ensuring customer satisfaction and patient safety. I am passionate about harnessing technology to make real differences in healthcare, and this dedication is the cornerstone of my leadership in the SaMD space.
Weronika Michaluk 0:00
Hi, I'm Weronika, and I'm Principal and software as medical device Practice Lead at HDD health. And at HDD health, we specialize in software as medical device design and development, so we can support companies from product ideation all the way to product market launch. So HTD health, we specialize in software as medical device design and development, and also in non medical software development. So what is important to mention is that we specialize only in healthcare software, and we support organizations from single entrepreneurs, from startups all the way to venture studios, medical centers, universities, research institutions, as well as big organizations like Smith and Nephew, Takeda Pharmaceuticals or Johnson and Johnson. And what we do, we can support different sizes of organization, from product ideation through design development, human factors, usability engineering, all the way to actually design verification, design validation and then successful product launch. As we bring lots of great experts that can help you know entrepreneurs with technology strategy, with business strategy, can help design and develop, not only intuitive software, but also very safe one, because we have to remember that then at the end of this, you know, journey, there is a patient that will be using our software. But we also hold very important certification. We are ISO 13, 485, certified. We also hold ISO 2701 27 Oh 18 certificates when we support our customers, we always value, you know, open, communication, transparency. We really care about our mutual values as we don't want to be just like another vendor that will just do the project and the relationship. We want to be your partner. We want to be your technology partner that will help you grow, that will help you get to this next stage. But another thing is that we bring you know different experts, so it's not only software engineers or designers, but also behavior change, design researchers, human factors, engineering experts, regulatory quality, usability engineering, all these experts come and create one project. If you need support from medical doctors, we have them on board as well. MDs, PhDs are part of our our organization, and thanks to that, we really bring on, you know, so many different perspectives to actually, then create diverse and successful team for our customers. You know, the future is bright. I always say the future is bright because we are expanding our footprint. So we are a global company. We are currently in US and in Europe, and we support so many different great partners, great organizations, and we want to touch, you know, lives of 10 billion patients by 2030 which is very doable for us, because we really work together with many organizations that have a great footprint. So you know, I just want to say that we will continue growing. We'll continue expanding our services and our expertise and just looking forward to the bright future. You.
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