Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
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AI Technology: For Regulatory Intelligence and Surveillance
Date & Time: Nov 26, 3 PM CET / 9 AM EST
Description:
Join us for an exclusive webinar featuring a panel of top experts in AI product development, regulatory affairs (RA), and quality assurance (QA) as they discuss how AI is transforming regulatory intelligence and surveillance. Our panelists will explore cutting-edge AI innovations and trends that empower organizations to monitor, analyze, and proactively respond to global regulatory changes. This session offers essential insights for building forward-thinking compliance strategies and highlights AI’s future role in shaping regulatory frameworks.
This event is ideal for professionals seeking actionable insights on leveraging AI for smarter, safer, and more efficient compliance—and understanding how these advancements are set to redefine the future of regulatory practices across industries.
Panel list
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CEO @ Qualtivate- consultancy helping life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.
Harsh Thakkar is the CEO of Qualtivate, a consultancy focused on transforming quality management and regulatory compliance in the life sciences industry. After witnessing the widespread challenges companies faced in managing massive amounts of data without gaining actionable insights, Harsh founded Qualtivate to streamline processes and simplify the regulatory landscape.
Under his leadership, Qualtivate has pioneered a new approach to integrate quality management directly into day-to-day operations. By eliminating inefficient manual processes, the company has helped over 15 life sciences organizations reduce time spent on tasks by up to 65%, enabling smarter, faster decision-making.
Harsh is passionate about helping organizations optimize their workflows, improve compliance, and embrace technology to stay competitive. Through his vision, Qualtivate has become a key partner for companies seeking smarter, data-driven solutions in their regulatory and quality management practices.
He also hosts Life Sciences 360, a podcast where he interviews industry leaders to explore the trends, challenges, and innovations shaping the life sciences sector.
LinkedIn:
Websites:
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CEO @ R2Decide | Venture Partner at Cherry.VC | Visiting Sr. Lecturer at Cornell | Forbes Contributor | Podcast Host
Lutz Finger is a leader in AI product development, focusing on building the next generation of generative AI tools as CEO of R2Decide. He is also a Venture Partner at Cherry.VC and a Senior Lecturer at Cornell University, where he teaches courses on building data products and data science. Additionally, Lutz shares his expertise as a contributor to Forbes, writing about data science, analytics, and data products.
With over a decade of experience in the data science and AI space, Lutz has significantly influenced both industry and academia. At R2Decide, he is working on pioneering AI products that are shaping the future of technology. His work at Cornell University involves educating future data leaders, emphasizing the importance of data science skills for business managers to foster innovation.
In his previous role as President of Product and Development at Marpai, Lutz utilized advanced technologies to enhance health benefits and reduce healthcare costs, impacting the well-being of countless individuals. He also served as a board member at Storytel, contributing to the next chapter of the company’s success.
With his extensive experience in both the startup ecosystem and corporate development, Lutz is passionate about leveraging AI and data science to solve complex, real-world challenges.
LinkedIn:
Websites:
lutzfinger.com (Blog)
miningdata.biz (Portfolio)
fisheyeanalytics.com (Company)
AI/ML in Healthcare Engineering and Regulatory Advisor | RSNA Booth #5647 | SaMD, SiMD, Gen AI | GTM Strategy | 510(k) in 3 months | End-to-End SaMD
With over a decade of experience in the Software as a Medical Device (SaMD) field, Dr. Yujan Shrestha has become an expert in navigating the complexities of AI/ML healthcare engineering and regulatory landscapes. His first FDA submission took over a year and involved multiple hold letters, but after 10+ submissions and five years of experience, Dr. Shrestha now helps companies clear 510(k) submissions in three months or less.
As a practicing AI/ML engineer and regulatory consultant, Dr. Shrestha has unique insight into bridging the gap between medical devices, technology, and regulation. His background allows him to bring both clinical knowledge and engineering expertise to help companies move AI/ML technologies from concept to the bedside.
He specializes in providing end-to-end services that guide medical device companies through the entire process—from ideation to 510(k) clearance. His focus includes SaMD, SiMD, and Generative AI, and he enjoys helping others navigate this challenging yet rewarding space.
Are you working on an AI/ML SaMD project? Dr. Shrestha is passionate about hearing your story and providing guidance to ensure your project is successful.
LinkedIn:
https://www.linkedin.com/in/yujanshrestha/
Website:
Regulatory Affairs & Quality Assurance Expert | Medical Device, IVD | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor
With over two decades of experience in the Medical Device and IVD industries, Martin King is a seasoned Regulatory Affairs and Quality Assurance expert. He is passionate about leveraging quality and regulatory frameworks as enablers to improve patient safety, accelerate time-to-market, and optimize operational costs. Martin specializes in ISO 13485, MDR 2017/745, IVDR 2017/746, FDA 21 CFR 820, Cybersecurity, and SaMD, helping organizations meet regulatory compliance while achieving business growth.
As a Lead Auditor and Person Responsible for Regulatory Compliance (PRRC), he brings hands-on experience in risk mitigation, crisis management, and sustaining business continuity under evolving regulatory conditions. Martin has contributed to multiple successful projects, from strategy development to post-market surveillance, and has demonstrated leadership in P&L management, team development, and cross-functional collaboration.
Currently open to new challenges, Martin is looking for opportunities to take a team or organization to the next level through strategic leadership in Regulatory Affairs and Quality Assurance. He believes in the power of effective compliance systems to drive business excellence.
LinkedIn:
https://www.linkedin.com/in/martink2/
LinkedIn Group:
For further details about the webinar, please contact Jonas Alfredsson at jonas_a@hoodin.com.