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"Advancing obesity and obesity-related trials with patients at the center of development.
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Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
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Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
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Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
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When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
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Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
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Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
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The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
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IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
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WHITE PAPER
Regulations and Reimbursement of Software as a Medical Device in Europe Part 2
Market entry and regulatory landscape
Apr 20, 2023
Over the past few decades, the development in software used alone or together with a medical device has increased significantly, this is due, in part, to the increased adoption of smart technology such as smartphones, wireless connectivity, cheaper and better sensors, cloud computing, big data and Artificial Intelligence (AI), which are influencing healthcare delivery across the world.
In part 2, we discuss Software as a Medical Device regulations specifically in Europe. We cover Medical Device Software (MDSW) regulations under the EU MDR and the EU IVD, how is it different from the SaMD definition, and we also highlight the key market entry challenges for digital health solutions into the European market.