Take advantage of the latest tools, techniques, and deep healthcare expertise to create scalable resources, precision insights, and actionable ideas.
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn moreDeveloping IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn moreDeveloping IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn moreDeveloping IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MOREReimagine 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.
Research & Development OverviewGenerate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEWElevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWOrchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWWhen your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWExplore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSAn in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTSBy 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.
LEARN MOREBuilding 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.
LEARN MOREYour 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.
LEARN MOREThe 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.
LEARN MOREThe 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.
LEARN MOREIQVIA 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.
LEARN MOREEmpowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
LEARN MORE"At IQVIA your potential has no limits. We thrive on bold ideas and fearless innovation. Join us in reimagining what’s possible.
VIEW ROLESLearn how thinking globally about enterprise quality management is key to meeting your customers' requirements and enhancing patient satisfaction.
Quality management is an integral factor in the development, approval and commercialization of medical devices and pharmaceutical products. This e-book provides insights on the challenges and opportunities in quality management, and highlights some best practices for creating Quality Nirvana.
Life Sciences organizations, including Medical Device, Pharmaceutical and Biotech manufacturers, are experiencing unprecedented levels of change in the regulatory and quality landscape. In this global economy, value chains (which include the demand chain and the supply chain) are getting longer and longer. Achieving quality and regulatory compliance in this environment can be quite overwhelming.
To focus in, we can look at some of the most recent changes in regulations and standards that have either been initiated/implemented, revised, or are in the process of revision, and that affect Quality Management Systems for Medical Device companies.
Unique Device Identifier (UDI): The first change is the introduction of Unique Device Identifier (UDI). UDI often generates discussion regarding “ownership” within an organization: Does ownership lie with Quality, Manufacturing, Engineering, etc; but at a minimum, the Device Identification (DI) – which identifies the labeler and the specific version or model of a device - needs to be captured on Nonconformances, CAPAs, and Complaints.
If the Production Identifier (PI) - which is the variable portion of the UDI and identifies one or more of the following: batch or lot number, serial number, expiration date, and/or manufactured date - is available for Nonconformance, CAPA and Complaints, all the better. This new requirement from the FDA also impacts labeling and submission to the FDA’s Global UDI Database (GUDID).
Take advantage of the latest tools, techniques, and deep healthcare expertise to create scalable resources, precision insights, and actionable ideas.
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.