Clinical Solutions
MedTech product development strategies to drive clinical studies.
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Impacting People's Lives
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.
Research & Development Overview
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.
REAL WORLD EVIDENCE OVERVIEW
Real World & Health Data Sets
Real World & Health Data Sets (desc)
Medical Affairs
Medical Affairs (desc)
IQVIA Health Communications Group
IQVIA Health Communications Group (desc)
Health Data Apps & AI
Health Data Apps & AI (desc)
Health Data Transformation
Health Data Transformation (desc)
Study Design
Study Design (desc)
Evidence Networks
Evidence Networks (desc)
Health Economics & Value
Health Economics & Value (desc)
Regulatory and Safety
Regulatory and Safety (desc)
Natural Language Processing
Natural Language Processing (desc)
Real World Evidence Library
Real World Evidence Library (desc)
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.
COMMERCIALIZATION OVERVIEW
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.
COMPLIANCE OVERVIEW
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.
TECHNOLOGIES OVERVIEW
Orchestrated Clinical Trials
Orchestrated Clinical Trials (desc)
Customer Engagement
Customer Engagement (desc)
Commercial Compliance
Commercial Compliance (desc)
Safety, Regulatory, Quality Compliance
Safety, Regulatory, Quality Compliance (desc)
Developer
Developer (desc)
Partner Programs
Partner Programs (desc)
Technology Insights
Technology Insights (desc)
The IQVIA difference
CLINICAL PRODUCTS
Planning Suite
Grant Plan
Site Suite
Clinical Trial Payments
Investigator Site Portal
One Home for Sites
Patient Engagement Suite
Electronic Clinical Outcome Assessment (eCOA)
Interactive Response Technology (IRT)
Clinical Data Analytics Solutions
COMMERCIAL PRODUCTS
Information Management
Launch Strategy & Management
Pricing & Market Access
Brand Strategy & Management
Promotional Engagement
Performance Management & Insights
Orchestrated Analytics
Next Best Action
Customer Engagement (OCE)
Patient Engagement and Support
COMPLIANCE, SAFETY, REG PRODUCTS
IQVIA Vigilance Platform
Commercial Compliance
Regulatory Compliance
RIM Smart
Quality Compliance
SmartSolve eQMS
Safety & Pharmacovigilance
REAL WORLD PRODUCTS
Health Data Apps & AI
Analytics Research Accelerator
Expert Ecosystem
AI Patient & HCP Profiling- Commercial
AI Patient & Provider Profiling- Med Affairs
AI Patient & HCP Profiling- Healthcare
Natural Language Processing
Market Access Insights
Direct-to-Patient Research
CASE STUDY
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTS
THE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
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At IQVIA your potential has no limits. We thrive on bold ideas and fearless innovation. Join us in reimagining what’s possible.
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Explore IQVIA by region
As a global community, IQVIA continuously invests and commits to advancing human health.
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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.