PUBLISHER: KBV Research | PRODUCT CODE: 1785267
PUBLISHER: KBV Research | PRODUCT CODE: 1785267
The North America Medical Device Testing, Inspection And Certification Outsourcing Market would witness market growth of 7.9% CAGR during the forecast period (2025-2032).
The US market dominated the North America Medical Device Testing, Inspection And Certification Outsourcing Market by Country in 2024, and would continue to be a dominant market till 2032; thereby, achieving a market value of $1,116 million by 2032. The Canada market is experiencing a CAGR of 10.2% during (2025 - 2032). Additionally, The Mexico market would exhibit a CAGR of 9.2% during (2025 - 2032).
The North America Medical Device Testing, Inspection, and Certification (TIC) Outsourcing Market has evolved significantly in recent decades, driven by technological innovation, stringent regulatory frameworks, and the growing complexity of medical devices. Historically, manufacturers in the U.S. and Canada conducted quality assurance and regulatory testing in-house. However, as medical devices became more advanced and regulatory oversight intensified, manufacturers began to face mounting challenges in meeting compliance and safety expectations.
Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and Health Canada have consistently reinforced the importance of pre-market approval, post-market surveillance, and quality systems regulation, which necessitate thorough product evaluation through qualified third-party agencies. These agencies, often accredited to ISO/IEC 17025 and ISO 13485 standards, are now essential to the North American device manufacturing ecosystem.
North America Market Trends:
The medical device industry in North America stands as one of the most innovative and tightly regulated sectors within global healthcare. As technological advancements continue to reshape patient diagnostics, monitoring, and therapeutic solutions, the demand for rigorous product testing, inspection, and certification has intensified. With the increasing complexity of medical devices-ranging from AI-driven diagnostics to wearable biosensors-the role of third-party service providers has become essential in ensuring safety, efficacy, and regulatory compliance.
1. Integration of Advanced Technologies in Medical Devices
The integration of advanced technologies such as artificial intelligence (AI) and machine learning (ML) into medical devices has significantly transformed the TIC outsourcing landscape. As of August 2024, the U.S. Food and Drug Administration (FDA) had authorized 950 AI or ML-enabled medical devices, a substantial increase from previous years . This surge necessitates specialized testing and certification processes to ensure these devices meet stringent safety and efficacy standards.
For instance, in April 2024, AEYE Health received FDA approval for its AI-powered system, AEYE-DS, designed to detect diabetic retinopathy using a handheld fundus camera . This device enables rapid, autonomous screening, highlighting the need for TIC services adept at evaluating AI-integrated medical technologies. Similarly, in September 2024, Apple secured FDA approval for a sleep apnea detection feature in its Apple Watch Series 9 and Ultra 2, emphasizing the growing intersection of consumer electronics and medical diagnostics.
These advancements underscore the imperative for TIC providers to develop expertise in assessing complex software algorithms, data security, and interoperability standards, ensuring that innovative medical devices are both safe and effective for patient use.
2. Emphasis on Regulatory Compliance and Quality Assurance
The evolving regulatory landscape has intensified the focus on compliance and quality assurance within the medical device industry. Manufacturers are increasingly outsourcing TIC services to navigate complex regulatory requirements and ensure product quality.
In October 2024, Terumo Corporation announced a strategic partnership with NAMSA, a leading Contract Research Organization (CRO), to accelerate the regulatory approval and commercialization of its medical devices . This collaboration exemplifies how manufacturers are leveraging external expertise to streamline compliance processes and maintain high-quality standards.
Outsourcing TIC services allows manufacturers to access specialized knowledge in regulatory affairs, quality management systems, and risk assessment, facilitating timely market entry and adherence to international standards.
State of Competition in North America:
The medical device sector in North America operates within one of the most stringent regulatory and innovation-intensive environments globally. In an era of increasing technological complexity, evolving health standards, and rising demand for patient safety, the role of third-party Testing, Inspection, and Certification (TIC) services has expanded significantly. Today, TIC outsourcing is no longer a cost-saving measure but a strategic imperative for manufacturers navigating the intricate path from product design to market approval. As medical devices become more software-driven and globally distributed, regulatory requirements across jurisdictions such as the U.S. Food and Drug Administration (FDA) and Health Canada continue to tighten, prompting an increasing reliance on specialized external TIC providers.
1. Market Fragmentation and Competitive Structure
The North America Medical Device TIC Outsourcing Market is moderately fragmented, characterized by a blend of global certification giants and regionally focused service providers. On one hand, multinational organizations like UL Solutions, TUV SUD, Intertek, and SGS dominate the landscape with extensive service portfolios and deep regulatory expertise. These players often hold multiple international accreditations and can cater to clients needing multi-jurisdictional compliance. On the other hand, several small to mid-sized firms provide niche TIC services tailored to specific device types such as in vitro diagnostics, wearables, or implantable devices. This fragmentation creates both opportunities and challenges, as specialized providers may excel in agility and customization, while large players benefit from economies of scale, broad geographic reach, and brand recognition. The market's competitive structure is thus defined by dual dynamics-dominance of key leaders in large contracts and procurement cycles, and growing importance of smaller, agile firms in specialized and emerging technology segments.
2. Service Differentiation and Specialization
Competition in the market is increasingly shifting from pricing toward differentiation based on service specialization, technological capability, and regulatory consultancy. Leading firms are offering not just core TIC services but also extended regulatory support, clinical validation, and lifecycle monitoring. For example, Intertek has expanded its capabilities in usability testing and human factors engineering to meet FDA's growing emphasis on user safety in device design. UL Solutions has focused on cybersecurity assessments for connected and software-driven medical technologies. Specialization has become a key competitive lever, especially as medical devices integrate more AI algorithms, wireless modules, and cloud connectivity. Firms that can certify both the physical product and its embedded software-while ensuring HIPAA, FDA, and ISO compliance-gain a distinct edge. As a result, TIC providers are increasingly investing in upgrading testing infrastructure, adopting simulation environments, and offering end-to-end support to serve the evolving needs of medical device manufacturers.
Service Outlook
Based on Service, the market is segmented into Testing, Inspection, and Certification.
Testing Segment:
Testing services involve verifying the safety, performance, biocompatibility, electrical safety, and mechanical integrity of medical devices. In North America, the Testing segment dominated the TIC outsourcing market in 2024 due to the surge in Class II and Class III medical device approvals and the integration of advanced features such as software components and wireless connectivity. Companies such as UL Solutions, Intertek Group, and SGS North America play significant roles in this segment.
For instance, in April 2024, UL Solutions expanded its medical device testing capabilities in Raleigh, North Carolina, focusing on electromechanical and software-driven devices. This facility includes simulation-based testing labs and caters to both start-ups and large OEMs that aim for FDA premarket approvals or Health Canada's licensing. Similarly, Intertek's Arlington Heights lab in Illinois supports biocompatibility testing under ISO 10993 standards, which has become increasingly crucial for wearable and implantable devices. The proliferation of wearable monitors, insulin pumps, and diagnostic kits-especially post-pandemic-has intensified demand for extensive lab testing under real-world scenarios.
Inspection Segment:
Inspection services are critical in ensuring the ongoing compliance of production processes and facilities with regulatory and safety standards. In North America, this segment gained significant traction in 2024 with increased regulatory audits, supply chain surveillance, and factory inspections prompted by FDA's re-emphasis on Good Manufacturing Practices (GMP) under 21 CFR Part 820.
SGS North America conducted several on-site inspections for ventilator and infusion pump production units across California and Massachusetts in 2024. This was prompted by a series of recalls that led manufacturers to seek proactive third-party inspection services. Furthermore, Bureau Veritas collaborated with contract manufacturing organizations (CMOs) in Texas to audit their component suppliers, ensuring traceability and reducing the risk of non-conformance amid FDA's warning letter crackdowns. The focus on traceability and raw material origin, especially for critical care devices and Class III implants, has driven growth in this segment.
Device Class Outlook
Based on Device Class, the market is segmented into Class II, Class III, and Class I.
Class II Devices
Class II devices are considered to have moderate to high risk and typically require more stringent regulatory oversight, including special controls and, in many cases, 510(k) premarket notifications. This segment accounted for the highest share of the North American market in 2024 due to the widespread use of these devices in diagnostic, therapeutic, and monitoring applications. Examples of Class II devices include infusion pumps, surgical drapes, powered wheelchairs, and diagnostic imaging systems. These devices must comply with performance standards and undergo rigorous testing for safety and effectiveness, fueling demand for third-party TIC services.
For instance, in July 2024, Intertek expanded its medical device testing capabilities in the U.S. by investing in new laboratories for electromechanical and electromagnetic compatibility (EMC) testing of diagnostic and monitoring equipment-most of which fall under Class II. UL Solutions also reported a significant increase in demand for 510(k) testing support for wearable glucose monitors and cardiovascular monitoring systems, which are popular Class II devices. The continuous innovation in this segment-such as smart wearable health monitors by Philips Healthcare-requires thorough clinical evaluations and performance testing, creating robust growth for TIC outsourcing.
Class III Devices
Class III devices, which are used to support or sustain human life or present a potential unreasonable risk of illness or injury, come with the most stringent regulatory requirements. These devices must undergo premarket approval (PMA), which involves comprehensive scientific and regulatory review. In 2024, Class III devices held the second-largest share of the North American TIC outsourcing market, largely driven by the expanding use of implantable devices such as pacemakers, cochlear implants, and prosthetic heart valves.
SGS North America and TUV SUD America have recently strengthened their collaboration with U.S.-based Class III device manufacturers for support in clinical testing, biocompatibility evaluations, and full lifecycle risk assessments. In March 2024, Medtronic partnered with TUV SUD to conduct risk-based testing and certification of its new implantable neurostimulators, aiming for expedited PMA clearance through third-party validation. Such partnerships illustrate how the rigorous and resource-intensive demands of Class III devices are increasingly being met by specialized TIC service providers.
End Use Outlook
Based on End Use, the market is segmented into Medical Device Companies, Pharmaceutical and Biotech Companies, and Other End Use.
Medical Device Companies - Dominant End-use Segment in North America
In 2024, medical device companies held the largest share in the North America Medical Device TIC Outsourcing Market, driven by their need for stringent regulatory compliance, product safety assurance, and global market access. North America-particularly the United States-serves as a global hub for medical device innovation, hosting some of the world's largest companies like Medtronic, Abbott, and Boston Scientific. These firms routinely outsource testing, inspection, and certification (TIC) services to navigate complex regulatory frameworks such as those set by the U.S. Food and Drug Administration (FDA) and Health Canada.
Medical devices in Class II and III categories, including implantable defibrillators, insulin pumps, and orthopedic implants, require extensive validation in terms of electrical safety, biocompatibility, sterilization, and software performance. Rather than investing heavily in in-house facilities, device companies increasingly turn to third-party TIC providers for speed, scalability, and independent verification.
Pharmaceutical and Biotech Companies
The pharmaceutical and biotechnology companies segment represents a rapidly expanding share of the North America Medical Device TIC Outsourcing Market. Although traditionally focused on drug development, many pharma and biotech firms now produce combination products-such as drug-delivery devices, autoinjectors, and wearable injectables-that fall under medical device regulations. These hybrid products require rigorous testing, inspection, and certification, making third-party TIC providers crucial allies in regulatory navigation.
North America's robust biopharmaceutical ecosystem-with global players like Pfizer, Johnson & Johnson, Amgen, and Gilead Sciences-has spurred demand for TIC outsourcing, particularly for combination devices and advanced therapies. For example, Pfizer's combination vaccine delivery devices, which include prefilled syringes and pen systems, undergo outsourced biocompatibility and extractables/leachables testing to comply with both drug and device regulations enforced by the U.S. FDA.
Based on Service, the market is segmented into Testing, Inspection, and Certification. Based on Device Class, the market is segmented into Class II, Class III, and Class I. Based on End Use, the market is segmented into Medical Device Companies, Pharmaceutical and Biotech Companies, and Other End Use. Based on countries, the market is segmented into U.S., Mexico, Canada, and Rest of North America.
List of Key Companies Profiled
North America Medical Device Testing, Inspection And Certification Outsourcing Market Report Segmentation
By Service
By Device Class
By End Use
By Country