U.S. Medical Device Testing, Inspection & Certification Outsourcing Market Size, Share & Trends Analysis Report By Service (Testing, Inspection, Certification), By Device Class (Class I, Class II, Class III), By End Use, And Segment Forecasts, 2025 - 2030

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.

Opportunity Analysis

Increasing complexity in device innovation, along with evolving regulatory frameworks from the FDA and international bodies, is driving demand for third-party expertise in areas such as biocompatibility testing, electrical safety validation, and software verification. Outsourcing allows manufacturers to accelerate time-to-market while mitigating compliance risks and operational costs.

The above figure illustrates evolving market potential across different stages of the medical device lifecycle, from R&D to post-market surveillance. Each descending block in the funnel represents a stage, with widening percentages indicating growing engagement or opportunity volume. The R&D phase, while crucial for innovation, shows lower opportunity due to limited outsourcing at early conceptual stages. As devices advance into preclinical testing and regulatory submission, the demand for outsourced testing and inspection increases significantly. The largest opportunities lie at the market launch and post-market surveillance stages, where manufacturers rely heavily on third-party certification, risk mitigation, and global compliance support. This structure reflects how commercial and compliance-driven pressures create concentrated demand downstream, where time-to-market and regulatory clarity become mission-critical. Though the chart is abstract, it captures the scalable role of TIC providers in de-risking the device pipeline and sustaining lifecycle performance.

Technological Advancements

Technological advancements are reshaping the landscape of the U.S. medical device testing, inspection, and certification outsourcing market by enabling more precise, faster, and scalable evaluation processes. Innovations such as digital twin technology are allowing virtual simulations of devices under real-world operating conditions, reducing the need for prolonged physical testing cycles. Non-invasive and high-resolution imaging tools are enhancing the accuracy of inspection procedures for micro-scale and implantable devices. In addition, the integration of natural language processing and AI-driven documentation tools is streamlining regulatory reporting and audit preparation, significantly reducing turnaround times. Advanced materials testing platforms now offer real-time monitoring of chemical compatibility, wear resistance, and thermal stability, which is critical for next-generation biomaterials and combination devices. As device architecture becomes more intricate, these technologies empower TIC providers to deliver customized validation pathways while maintaining compliance with evolving FDA and international standards.

Pricing Analysis

The pricing model analysis of the market is becoming increasingly adaptive as service providers respond to various client expectations and project complexities. Manufacturers developing AI-integrated, connected, or high-risk devices often seek pricing models that allow iterative feedback, real-time adjustments, and phased testing, prompting the shift toward more hybrid or customized pricing schemes. Service bundling is also gaining ground, where TIC firms offer a package of design verification, risk management, and compliance documentation under a unified commercial agreement. These bundled offerings often reduce procurement overheads for clients while giving providers an opportunity to embed value-added services. Moreover, the rise of digital platforms for test management and remote inspections is influencing how contracts are priced, monitored, and scaled.

Service Insights

The testing segment captured the highest market share in 2024. The growth of the segment is due to the increasing complexity of medical devices, especially those integrating software, sensors, and wireless capabilities, which demand rigorous functional and safety testing before market entry. Regulatory bodies such as the U.S. FDA have also emphasized device-specific performance standards, further driving the need for external testing providers with specialized infrastructure and expertise.

The certification segment is projected to experience the fastest growth due to increasing demand for formal regulatory approvals and third-party attestations across both Class II and Class III medical devices. Rising scrutiny from authorities on product labeling, claims, and safety documentation has made certification services essential for successful commercialization.

Device Class Insights

The Class II segment dominated the market in 2024. The growth of the segment can be attributed to the increasing number of diagnostic and therapeutic devices falling under this classification, including infusion pumps, surgical drapes, powered wheelchairs, and blood pressure monitors. These devices require performance and safety validation that is more extensive than Class I, but not as rigorous as Class III, making them highly dependent on third-party testing, inspection, and certification services.

The Class I segment is projected to witness lucrative growth during the forecast period. The growth of the segment is mainly attributed to the proliferation of low-risk devices such as bandages, examination gloves, handheld surgical instruments, and other routine-use items that still require compliance with general safety and labeling controls. Although regulatory burdens are comparatively lower for Class I devices, recent emphasis on supply chain transparency, sterility assurance, and post-market surveillance has increased the need for structured testing and certification, particularly for manufacturers aiming for international market access.

End Use Insights

The medical device companies segment dominated the market in 2024 due to the rising complexity of device innovation, increased regulatory oversight, and the need for accelerated time-to-market. As companies expand their product portfolios to include smart devices, minimally invasive systems, and AI-integrated diagnostics, the reliance on third-party expertise for performance validation, quality assurance, and regulatory compliance has intensified. Furthermore, stringent FDA requirements, particularly for Class II and III devices, have made outsourcing an essential strategy for navigating technical file preparation, risk assessment, and labeling verification.

The pharmaceutical and biotech companies segment is projected to witness a lucrative growth from 2025 to 2030. The growth is due to the rising collaboration between drug and device technologies, especially in the development of combination products, drug-delivery systems, and digital therapeutics. These hybrid solutions demand rigorous and multi-dimensional testing that spans both pharmaceutical and medical device regulatory frameworks. Biotech firms developing innovative delivery mechanisms, such as autoinjectors, implantable pumps, and inhalation devices, increasingly require outsourced partners to support end-to-end compliance from material biocompatibility to software validation.

Key U.S. Medical Device Testing, Inspection & Certification Outsourcing Companies Insights

Key players operating in the U.S. medical device testing, inspection & certification outsourcing market are undertaking various initiatives to strengthen their presence and increase the reach of their products and services. Strategies such as expansion activities and partnerships are key in propelling the market growth.

Recent Developments

• In July 2024, Element Materials Technology launched RegNav, an AI-driven regulatory intelligence platform aimed at streamlining the FDA submission process for medical devices, supporting manufacturers in identifying applicable regulations and testing requirements efficiently.

• In November 2023, Nelson Labs entered into a collaboration agreement with the BSI, a product testing company. This partnership aims to enhance global regulatory navigation and accelerate certification timelines for medical devices. The collaboration strengthens PPE supply chains by integrating testing and compliance expertise.

• In October 2023, UL Solutions announced to expand its medical device testing services in the U.S., which aims to support the country’s growing MedTech sector. The new capabilities will help manufacturers enhance product safety, security, and interoperability.
  

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

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