미국의 의료기기 시험, 검사 및 인증 아웃소싱 시장 : 규모, 점유율, 동향 분석(서비스별, 기기 클래스별, 최종 용도별), 부문별 예측(2025-2030년)

Market Size & Trends:

The U.S. medical device testing, inspection & certification outsourcing market size was estimated at USD 552.5 million in 2024 and is projected to grow at a CAGR of 9.0% from 2025 to 2030. The growth is driven by the increasing demand for regulatory compliance, the increasing technological complexity of medical devices, especially those with digital health features, and the growing need for faster time-to-market. These trends are driving device manufacturers to partner with experienced TIC providers to meet safety and quality standards, optimize development cycles, and ensure regulatory alignment across global markets.

Rising regulatory complexity in the U.S. medical device industry is prompting a notable shift toward outsourcing of testing, inspection, and certification services. Manufacturers are navigating a landscape shaped by more rigorous FDA guidelines covering cybersecurity protocols, usability engineering, and biocompatibility testing. These demands have made in-house regulatory compliance increasingly resource-intensive, especially for small and mid-sized firms. As a result, medical device companies are turning to specialized TIC providers with deep regulatory knowledge and accredited infrastructure. These firms not only help navigate 510(k) and PMA pathways but also provide documentation and data needed for regulatory submissions. The partnership reduces internal operational burden and improves the accuracy and completeness of testing outputs.

The increasing complexity of medical devices, particularly with the integration of digital and connected technologies, is intensifying demand for specialized validation and performance testing. Several modern devices now include embedded software, wireless modules, AI-powered diagnostics, and sensor technologies that require advanced testing environments and simulation tools. In-house teams often lack the capabilities to validate these features against real-world conditions or emerging safety standards. TIC providers offer tailored services such as software lifecycle testing, electromagnetic compatibility (EMC) assessments, wireless signal reliability testing, and cloud platform security evaluations. These services are becoming essential as the market shifts toward wearable health monitors, remote diagnostic tools, and robotic-assisted surgical systems. The growing reliance on such devices in both clinical and home settings necessitates more comprehensive testing, which many companies are outsourcing to accelerate development. As device functionalities evolve to meet new clinical demands, outsourcing allows manufacturers to keep pace with innovation while maintaining robust safety validation.

U.S. Medical Device Testing, Inspection & Certification Outsourcing Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. medical device testing, inspection, and certification outsourcing market report based on service, device class, and end use.

• Service Outlook (Revenue, USD Million, 2018 - 2030)
• Testing
• Inspection
• Certification
• Device Class Outlook (Revenue, USD Million, 2018 - 2030)
• Class I
• Class II
• Class III
• End Use Outlook (Revenue, USD Million, 2018 - 2030)
• Medical Device Companies
• Pharmaceutical and Biotech Companies
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
  • 1.1.1. Regional Scope
  • 1.1.2. Estimates and Forecast Timeline
• 1.2. Market Definitions
• 1.3. Research Methodology
  • 1.3.1. Information Procurement
  • 1.3.2. Purchased Database
  • 1.3.3. GVR's Internal Database
  • 1.3.4. Secondary Sources
  • 1.3.5. Primary Research
• 1.4. Information or Data Analysis
  • 1.4.1. Information Analysis
  • 1.4.2. Market Formulation & Data Visualization
  • 1.4.3. Data Validation & Publishing
• 1.5. Model Details
  • 1.5.1. Commodity Flow Analysis (Model 1)
  • 1.5.2. Top Down Market Estimation (Model 2)
  • 1.5.3. Value-Chain-Based Sizing & Forecasting (Model 3)
  • 1.5.4. Multivariate Analysis (Model 4)
• 1.6. List of Secondary Sources
• 1.7. List of Abbreviations
• 1.8. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Insights Landscape

Chapter 3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook.
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. Industry Market Analysis Tools
  • 3.5.1. Industry Analysis - Porter's
  • 3.5.2. PESTEL Analysis
  • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Service Movement Analysis
• 4.3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
• 4.4. Testing
  • 4.4.1. Testing market estimates and forecasts, 2018 - 2030 (USD Million)
• 4.5. Inspection
  • 4.5.1. Inspection market estimates and forecasts, 2018 - 2030 (USD Million)
• 4.6. Certification
  • 4.6.1. Certification market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market: Device Class Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Device Class Movement Analysis
• 5.3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Size & Trend Analysis, by Device Class, 2018 to 2030 (USD Million)
• 5.4. Class I
  • 5.4.1. Class I market estimates and forecasts, 2018 - 2030 (USD Million)
• 5.5. Class II
  • 5.5.1. Class II market estimates and forecasts, 2018 - 2030 (USD Million)
• 5.6. Class III
  • 5.6.1. Class III market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market: End Use Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market End Use Movement Analysis
• 6.3. U.S. Medical Device Testing, Inspection, and Certification Outsourcing Market Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
• 6.4. Medical Device Companies
  • 6.4.1. Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
• 6.5. Pharmaceutical and Biotech Companies
  • 6.5.1. Pharmaceutical and biotech companies market estimates and forecasts, 2018 - 2030 (USD Million)
• 6.6. Others
  • 6.6.1. Others market estimates and forecasts, 2018 - 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Competition Categorization
• 7.2. Company Market Share/Assessment Analysis, 2024
• 7.3. Company Profiles
  • 7.3.1. SGS SA
    • 7.3.1.1. Company overview
    • 7.3.1.2. Financial performance
    • 7.3.1.3. Service benchmarking
    • 7.3.1.4. Strategic initiatives
  • 7.3.2. Intertek Group plc
    • 7.3.2.1. Company overview
    • 7.3.2.2. Financial performance
    • 7.3.2.3. Service benchmarking
    • 7.3.2.4. Strategic initiatives
  • 7.3.3. Eurofins Scientific SE
    • 7.3.3.1. Company overview
    • 7.3.3.2. Financial performance
    • 7.3.3.3. Service benchmarking
    • 7.3.3.4. Strategic initiatives
  • 7.3.4. DEKRA CERTIFICATION B.V.
    • 7.3.4.1. Company overview
    • 7.3.4.2. Financial performance
    • 7.3.4.3. Service benchmarking
    • 7.3.4.4. Strategic initiatives
  • 7.3.5. UL Solutions Inc.
    • 7.3.5.1. Company overview
    • 7.3.5.2. Financial performance
    • 7.3.5.3. Service benchmarking
    • 7.3.5.4. Strategic initiatives
  • 7.3.6. TUV SUD
    • 7.3.6.1. Company overview
    • 7.3.6.2. Financial performance
    • 7.3.6.3. Service benchmarking
    • 7.3.6.4. Strategic initiatives
  • 7.3.7. ALS Limited
    • 7.3.7.1. Company overview
    • 7.3.7.2. Financial performance
    • 7.3.7.3. Service benchmarking
    • 7.3.7.4. Strategic initiatives
  • 7.3.8. Bureau Veritas SA
    • 7.3.8.1. Company overview
    • 7.3.8.2. Financial performance
    • 7.3.8.3. Service benchmarking
    • 7.3.8.4. Strategic initiatives
  • 7.3.9. Element Materials Technology
    • 7.3.9.1. Company overview
    • 7.3.9.2. Financial performance
    • 7.3.9.3. Service benchmarking
    • 7.3.9.4. Strategic initiatives
  • 7.3.10. Nelson Labs
    • 7.3.10.1. Company overview
    • 7.3.10.2. Financial performance
    • 7.3.10.3. Service benchmarking
    • 7.3.10.4. Strategic initiatives