North America Medical Device Testing, Inspection And Certification Outsourcing Market Size, Share & Industry Analysis Report By Service, By Device Class, By End Use, By Country and Growth Forecast, 2025 - 2032

The North America Medical Device Testing, Inspection And Certification Outsourcing Market is expected to 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 is expected to continue to be a dominant market till 2032; thereby, achieving a market value of $1.11 billion by 2032. The Canada market is experiencing a CAGR of 10.2% during 2025-2032. Additionally, the Mexico market is expected to exhibit a CAGR of 9.2% during 2025-2032.



New technologies, stricter rules, and the fact that medical devices are getting more complicated have all changed the North America Medical Device Testing, Inspection, and Certification (TIC) Outsourcing Market a lot in the last few decades. Quality assurance and regulatory testing utilized to be done by companies in the U.S. and Canada on their own time. But as medical devices got better and more rules were made, it became harder for companies to meet safety and compliance standards.

Strong Oversight by U.S. and Canadian Regulators

• Focus on Safety from Start to Finish: The FDA (U.S.) and Health Canada make sure medical devices are safe - before they reach the market and even after they're sold.
• Rules for Quality and Monitoring: These agencies require that products go through strict quality checks and long-term monitoring.

Role of Trusted Third-Party Agencies

• Independent Testing Experts: Certified outside agencies now help companies test and inspect medical devices to meet safety rules.
• Global Standards Matter: These agencies follow international quality standards (like ISO 17025 and 13485), making them trusted partners in the U.S. and Canadian healthcare industry.

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, TÜV SÜD, 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 check to make sure that medical devices are safe, work well, are biocompatible, electrically safe, and mechanically sound. In 2024, the Testing segment was the biggest part of the TIC outsourcing market in North America. This was because there were more approvals for Class II and Class III medical devices and because new features like software components and wireless connectivity were added. In this area, UL Solutions, Intertek Group, and SGS North America are all very important companies.

For example, UL Solutions added more medical device testing capabilities in Raleigh, North Carolina, in April 2024. The company focused on devices that use software and electromechanical systems. This facility has testing labs that use simulations and is open to both new businesses and big OEMs that want FDA premarket approvals or Health Canada's licenses. Intertek's Arlington Heights lab in Illinois also supports biocompatibility testing under ISO 10993 standards, which is becoming increasingly important for devices that can be worn or implanted. The rise in wearable monitors, insulin pumps, and diagnostic kits - especially after the pandemic - has increased the need for extensive lab testing in real-world situations.

Inspection Segment

It is very important to have inspection services to make sure that production processes and facilities continue to follow safety and regulatory standards. In North America, this part grew a lot in 2024 because the FDA put more emphasis on Good Manufacturing Practices (GMP) under 21 CFR Part 820. This led to more regulatory audits, supply chain surveillance, and factory inspections.

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 thought to have a moderate to high risk, so they usually need more strict regulatory oversight. This includes special controls and, in many cases, 510(k) premarket notifications. This segment had the biggest share of the North American market in 2024 because these devices were widely used for diagnosis, treatment, and monitoring. Infusion pumps, surgical drapes, powered wheelchairs, and diagnostic imaging systems are all examples of Class II devices. These devices must meet performance standards and go through a lot of testing to make sure they are safe and work well. This has led to a high demand for third-party TIC services.

For example, in July 2024, Intertek improved its ability to test medical devices in the U.S. by building new labs for testing the electromagnetic and electromechanical compatibility (EMC) of diagnostic and monitoring equipment, most of which are Class II devices. UL Solutions also said that there has been a big rise in demand for 510(k) testing help for wearable glucose monitors and cardiovascular monitoring systems, which are popular Class II devices. Philips Healthcare's smart wearable health monitors are just one example of how this area is always coming up with new ideas. This means that TIC outsourcing is growing quickly because it needs thorough clinical evaluations and performance testing.

Class III Devices

Class III devices are the most strictly regulated because they are used to support or sustain human life or pose an unreasonable risk of illness or injury. Scientists and regulators have to look over these devices very carefully before they can be sold. This is called premarket approval (PMA). In 2024, Class III devices were the second biggest group in the North American TIC outsourcing market. This was mostly because more people were getting cochlear implants, pacemakers, and prosthetic heart valves that could be put in their bodies.

SGS North America and TÜV SÜD America have been working more closely with Class III device makers in the U.S. to help them with clinical testing, biocompatibility evaluations, and full lifecycle risk assessments. Based on risk, Medtronic and TÜV SÜD tested and certified its new implantable neurostimulators in March 2024. The goal was to speed up the PMA clearance process by getting it validated by a third party. These kinds of partnerships show that TIC service providers are getting better at meeting the strict and resource-intensive needs of Class III devices.

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 into 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.

List of Key Companies Profiled

• SGS S.A.
• Intertek Group PLC
• Eurofins Scientific SE
• TUV SUD
• ALS Limited
• Bureau Veritas S.A.
• Element Materials Technology (Temasek Holdings)
• DNV AS
• Pace Analytical Services, LLC
• Nelson Laboratories, LLC (Sotera Health Company)

Market Report Segmentation

By Service

• Testing
• Inspection
• Certification

By Device Class

• Class II
• Class III
• Class I

By End Use

• Medical Device Companies
• Pharmaceutical and Biotech Companies
• Other End Use

By Country

• US
• Canada
• Mexico
• Rest of North America