美国医疗设备测试、检验和认证外包市场：市场规模、份额、趋势分析（按服务、设备类别和最终用途）、细分预测（2025-2030 年）

市场规模与趋势：

美国医疗设备测试、检验和认证外包市场规模预计在2024年达到5.525亿美元，预计2025年至2030年期间的复合年增长率为9.0%。推动这一成长的因素包括：法规合规性要求日益提高、医疗设备（尤其是具备数位医疗功能的设备）的技术复杂性日益提升，以及对缩短时间的需求日益增长。这些全球趋势促使设备製造商与经验丰富的测试、检验和认证 (TIC) 供应商合作，以满足安全和品质标准，优化开发週期，并确保全球市场的监管一致性。

美国医疗设备业产业日益复杂的监管环境正推动测试、检验和认证服务向外包方向的显着转变。製造商正在应对由更严格的 FDA 指南所塑造的市场环境，这些指南涵盖资源彙整通讯协定、可用性工程、生物相容性测试等。这些要求使得内部监管合规工作越来越耗费资源，尤其对于规模较小的公司。因此，医疗设备公司正在转向拥有深厚监管知识和认证基础设施的专业 TIC 提供者。这些公司不仅帮助企业完成 510(k) 和 PMA 审批流程，还提供提交监管文件所需的文件和资料。这种伙伴关係减轻了内部业务负担，并提高了测试结果的准确性和完整性。

医疗设备日益复杂，尤其是数位技术和互联技术的整合，推动了对专门验证和效能测试的需求。现代医疗设备包括嵌入式软体、无线模组、人工智慧诊断和感测器技术，这些都需要先进的测试环境和模拟工具。内部团队通常缺乏根据实际条件和新安全标准检验这些功能的能力。 TIC 供应商提供客製化服务，例如软体生命週期测试、电磁相容性 (EMC) 评估、无线讯号可靠性测试和云端平台安全性评估。随着市场转向穿戴式健康监测器、远距离诊断工具和机器人辅助手术系统，这些服务变得至关重要。临床和家庭环境中对此类设备的依赖性日益增加，需要更全面的测试，许多公司正在外包以加速开发。随着设备功能不断发展以满足新的临床需求，外包使製造商能够跟上技术创新，同时保持强大的安全检验。

目录

第一章 分析方法与范围

第二章执行摘要

第三章美国医疗设备测试、检验和认证外包市场：驱动因素、趋势和范围

• 市场联动展望
  • 母市场展望
  • 相关/附随市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制分析
• 技术状况
• 定价模式分析
• 产业和市场分析工具
  • 产业分析：波特五力分析
  • PESTEL分析
  • COVID-19影响分析

第四章美国医疗设备测试、检验和认证外包市场：按服务分類的估计和趋势分析

• 细分仪表板
• 美国医疗设备测试、检验和认证外包市场：按服务分类的趋势分析
• 美国医疗设备测试、检验和认证外包市场规模和趋势分析（按服务划分）（2018-2030 年）
• 测试
• 检查
• 认证

第五章美国医疗设备测试、检验和认证外包市场：按设备类别的估计和趋势分析

• 细分仪表板
• 美国医疗设备测试、检验和认证外包市场：按设备类别进行趋势分析
• 美国医疗设备测试、检验及认证外包市场规模及趋势分析（按设备类别）（2018-2030）
• I类
• II 类
• III 类

第六章：美国医疗设备测试、检验和认证外包市场：依最终用途的估计和趋势分析

• 细分仪表板
• 美国医疗设备测试、检验和认证外包市场：按最终用途进行趋势分析
• 美国医疗设备测试、检验和认证外包市场规模和趋势分析（按最终用途）（2018-2030 年）
• 医疗设备公司
• 製药和生物技术公司
• 其他的

第七章 竞争态势

• 竞争性分类
• 公司市场占有率/估值分析（2024年）
• 公司简介
  • SGS SA
  • Intertek Group plc
  • Eurofins Scientific SE
  • DEKRA CERTIFICATION BV
  • UL Solutions Inc.
  • TUV SUD
  • ALS Limited
  • Bureau Veritas SA
  • Element Materials Technology
  • Nelson Labs

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

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 U.S. Medical Device Testing, Inspection & Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 4 U.S. Medical Device Testing, Inspection & Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 5 U.S. Medical Device Testing, Inspection & Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Medical Device Testing, Inspection and Certification Outsourcing, Market Segmentation
• Fig. 2 Market research process
• Fig. 3 Information Procurement
• Fig. 4 Primary Research Pattern
• Fig. 5 Market Research Approaches
• Fig. 6 Value Chain-Based Sizing & Forecasting
• Fig. 7 Market Formulation & Validation
• Fig. 8 Market Dynamics
• Fig. 9 Market Driver Relevance Analysis (Current & Future Impact)
• Fig. 10 Market Restraint Relevance Analysis (Current & Future Impact)
• Fig. 11 Porter's Five Forces Analysis
• Fig. 12 PESTEL by SWOT Analysis
• Fig. 13 Country Marketplace: Key Takeaways
• Fig. 14 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Testing, 2018 - 2030 (USD Million)
• Fig. 15 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Inspection, 2018 - 2030 (USD Million)
• Fig. 16 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Certification, 2018 - 2030 (USD Million)
• Fig. 17 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Class I, 2018 - 2030 (USD Million)
• Fig. 18 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Class II, 2018 - 2030 (USD Million)
• Fig. 19 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Class III, 2018 - 2030 (USD Million)
• Fig. 20 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Medical Device Companies, 2018 - 2030 (USD Million)
• Fig. 21 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Pharmaceutical and Biotech Companies, 2018 - 2030 (USD Million)
• Fig. 22 U.S. Medical Device Testing, Inspection & Certification Outsourcing, for Others, 2018 - 2030 (USD Million)