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Impacting People's Lives

"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.

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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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Real World Evidence. Real Confidence. Real Results.

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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See markets more clearly. Opportunities more often.

Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.

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Service driven. Tech-enabled. Integrated compliance.

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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Intelligence that transforms life sciences end-to-end.

When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.

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"Data in a Day

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Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

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THE IQVIA INSTITUTE

An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.

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INSTITUTE REPORT

"Global Trends in R&D 2023

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EMEA Insights

"IQVIA thought leadership with a focus on EMEA.

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WHITE PAPER

"DCTs Deliver Big ROI

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WHITE PAPER

"Capturing value at scale: The $4 billion RWE imperative

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FEATURED INNOVATIONS
  • Connected Intelligence
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  • Human Data Science Cloud
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INVESTOR RELATIONS

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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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AI & Machine Learning with a healthcare IQ.

Artificial intelligence is accelerating opportunities. Realizing the benefits for healthcare requires the right expertise. Together, we can solve the problems of today, and drive the breakthroughs of tomorrow.

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Your healthcare data deserves more than just a cloud.

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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Innovations make an impact when bold ideas meet powerful partnerships

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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Proven, faster DCT solutions

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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Unlock the power of genomic research.

IQVIA enables genomic research via global access to a network of genomic-clinical data, proprietary technologies that enable federated analytics, and therapeutic area & bioinformatics expertise to help you answer your most pressing research questions.

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WORKING AT IQVIA

Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.

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LIFE AT IQVIA

Careers, culture and everything in between. Find out what’s going on right here, right now.

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"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.

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Fact Sheet
Understanding the Regulatory Pathway for 510k Submissions
Leverage medical device expertise for your latest innovation to healthcare
Oct 31, 2022
  • Library
  • Understanding the Regulatory Pathway for 510(k) Submissions

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Most medical devices gain marketing clearance in the United States through a pre-market notification, also known as a 510(k) submission. Preparing a 510(k) can be challenging. IQVIA MedTech offers professional services from strategic regulatory advice and marketing applications to regulatory maintenance. We are here to help you remediate and streamline your timely FDA submissions.

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MedTech

Forging a path for MedTech Innovation.

Industry Segments

See how we partner with organizations across the healthcare ecosystem, from emerging biotechnology and large pharmaceutical, to medical technology, consumer health, and more, to drive human health forward.

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