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市场调查报告书
商品编码
1785249
全球医疗设备测试、检验和认证外包市场规模、份额和行业分析报告(按服务、设备类别、最终用途和地区、展望和预测,2025-2032 年)Global Medical Device Testing, Inspection And Certification Outsourcing Market Size, Share & Industry Analysis Report By Service, By Device Class, By End Use, By Regional Outlook and Forecast, 2025 - 2032 |
预计到 2032 年,医疗设备测试、检验和认证外包市场规模将达到 54.8 亿美元,预测期内的复合年增长率为 8.3%。
主要亮点:
过去几十年来,受医疗技术快速发展、监管审查力度加大以及医疗保健产品分销全球化的推动,医疗设备测试、检验和认证 (TIC) 外包市场发生了显着变化。最初,许多医疗设备製造商在内部管理其品质保证和法规合规流程。然而,随着器械复杂性和多样性的增加,以及美国食品药物管理局(FDA)、欧洲药品管理局 (EMA) 和日本医疗器材製造商协会 (PMDA) 等全球卫生机构实施严格的合规框架,外包成为一种策略必需。
医疗设备公司开始更依赖第三方TIC服务供应商来遵守国内和国际标准,提高产品品质,并加快上市时间。跨区域医疗设备需求的成长也推动了这一趋势,迫使製造商满足多样化的监管要求,并转向在多个司法管辖区拥有专业知识的专业服务提供者。
随着时间的推移,TIC 职能外包有助于企业降低成本、规避风险,并专注于创新和产品开发等核心竞争力。欧盟和北美的政府卫生机构和认证机构在製定安全标准和测试通讯协定方面发挥关键作用,这进一步强化了独立检验和确认的必要性。新兴国家医疗基础设施的扩张以及医疗设备数位化的日益发展将进一步增加对 TIC 外包的依赖,从而创造一个蓬勃发展且不断发展的全球市场。
影响医疗设备TIC外包市场的关键趋势之一是先进技术与设备的集成,这迫切需要新的测试能力。整合了用于诊断的AI演算法、用于远端监控的物联网感测器以及软体驱动的治疗性介入的设备需要进行网路安全、数据准确性和即时功能测试。传统的测试方法不足以评估这些新组件,迫使TIC供应商投资高科技实验室和数位化能力,以保持竞争力。
另一个主要趋势是,受产品召回和病人安全问题等全球性事件的推动,合规性的重要性日益提升。监管机构正在提高品质保证的标准,这使得独立的TIC服务对于寻求获得并维持FDA 510(k)、CE标誌和ISO 13485等认证的公司至关重要。合规性不再是一次性活动,而是一项持续的要求,需要在整个产品生命週期中与您的TIC提供者持续合作。
市场整合分析
由于法规日益严格、医疗供应链全球化以及医疗设备技术的快速发展,全球医疗设备TIC市场正经历重大变革时期。测试、检验和认证 (TIC) 服务确保製造商和监管机构的产品安全性、合规性和可靠性。随着这些服务日益专业化,市场正在整合,少数跨国TIC供应商透过提供整合、扩充性且全球协调的解决方案占据主导地位。市场整合受到多种因素的影响,包括创新、监管负担、进入障碍和国际伙伴关係关係,所有这些因素都将决定市场力量的分配和未来的成长轨迹。
1. 创新程度-★★★★☆(4/5)
医疗设备TIC市场的创新围绕着测试自动化、人工智慧诊断和数位检测系统。 TUV SUD、SGS和Intertek等公司正在实施基于机器学习的测试框架和数数位双胞胎,用于预测检验,从而显着扩展测试范围并缩短测试週期。
基础:
创新是动态的,但它是渐进式的,而非颠覆性的。核心测试方法与国际标准息息相关,限制了彻底创新的空间。然而,流程数位化和人工智慧整合的创新提供了适度的竞争差异化,使中型和大型企业获得优势,同时也为二级企业留下了在地化创新的空间。
产品生命週期分析:
产品生命週期 (PLC) 框架有助于了解特定产业的成熟度、竞争趋势、投资重点和策略规划。在全球医疗设备TIC(测试、检验和认证)市场中,PLC 分析可帮助相关人员了解市场现状、每个阶段的挑战和机会,以及主要企业如何适应不断变化的监管、技术和客户环境。该分析整合了 TIC 主要参与者的过往发展、当前趋势和策略倡议。
1. 引入阶段
21世纪初,随着美国食品药物管理局 (FDA)、欧洲药品管理局 (EMA) 和日本药品管理局 (PMDA) 等监管机构开始加强合规性和品质标准,医疗设备TIC外包市场开始蓬勃发展。第三方验证的需求激增。在此期间,TIC仍然主要由製造商内部处理。儘管TUV SUD和SGS是少数几家提供独立服务的全球公司之一,但由于对资料隐私和外包生态系统不发达的担忧,人们对采用这些服务持谨慎态度。
此阶段市场认知度较低、客製化程度高、服务成本高、合约谈判週期长,TIC公司需要向OEM厂商宣传独立检验的优势。
2. 成长阶段
2010年至2020年左右,医疗器材市场进入快速增长期,推动因素包括全球医疗设备出口扩张、遵守多国复杂法规(例如欧洲医疗器材法规 (MDR))的需求,以及植入和穿戴式装置等新型设备的激增。 2017年生效的《欧盟医疗设备法规》(EU MDR) 为医疗器材市场带来了转捩点,它增加了对严格测试和记录的需求。
Intertek、必维国际检验集团 (Bureau Veritas) 和 UL Solutions 等领先公司已扩展其在亚太地区和中东地区的服务,以满足原始设备製造商 (OEM) 对全球市场准入的需求。例如,SGS 于 2019 年扩建了其位于上海的生命科学实验室,以增强其针对 II 类和 III 类医疗器材的生物相容性测试能力,从而获得国际认证。
3.成熟阶段
全球医疗设备TIC外包市场目前正处于成熟阶段。至2024年,市场将实现显着整合,届时TUV Rheinland、Eurofins Scientific和SGS等公司将提供产品安全、网路安全认证、软体检验等端到端服务。
预计到 2024 年,测试将占据约 65.1% 的市场占有率,需求将转向更标准化和重复性的服务,特别是在法规合规性更新和连接设备的网路安全评估方面。
最近的例子包括 UL Solutions 于 2023 年与日本 NTT Data 合作开发用于人工智慧诊断工具的安全认证通讯协定,Intertek 于 2022 年收购 SAI Global Assurance 以加强其北美医疗设备部门。
4. 饱和与早期衰退
儘管核心TIC服务已经成熟,但传统设备领域预计在已开发国家将达到饱和。然而,人工智慧整合设备、机器人手术系统和个人化诊断仍有成长空间。例如,必维国际检验集团于2023年推出了其智慧健康TIC倡议,目标是基于人工智慧的诊断成像工具和穿戴式感测器。
随着 TIC 成为一种商品,数位测试、远端检查和即时合规分析等附加价值服务将决定未来的差异化,但如果没有创新,服务利润率将逐渐下降。
5. 结论与市场现状
基于上述分析,全球医疗设备TIC外包市场正处于其产品生命週期的成熟阶段。该市场的特点是需求强劲、服务标准化程度高、主要企业积极进行全球扩张,以及为避免商品化而不断创新。然而,由于监管顺风顺水、设备技术进步以及跨境贸易成长,专业领域和服务匮乏的地区仍有成长空间。
COVID-19影响分析
新冠疫情对医疗设备测试、检验和认证 (TIC) 外包市场产生了负面影响。最初,全球封锁和供应链中断导致製造和测试业务延迟。许多非必需和非必需医疗设备医疗设备的产量下降,从而降低了对 TIC 服务的需求。此外,现场审核和检验的限制也扰乱了认证流程。因此,新冠疫情在初期就对市场产生了负面影响。
市场成长要素
这一趋势最引人注目的例子之一是人工智慧医疗设备在北美市场的激增。截至2024年8月,FDA已核准了950种支援人工智慧或机器学习的医疗设备,较2020年初的数十种大幅成长。这种快速成长反映了数位科技在医疗保健领域日益增长的作用,以及FDA对自主和半自动决策支援工具不断变化的监管方法。这为提供上市后监测、真实世界证据(RWE)收集和软体生命週期审核的TIC供应商创造了新的需求。
此外,快速的技术进步正在显着改变北美医疗设备格局,推动创新并重塑患者照护。这些进步不仅提高了诊断和治疗能力,还需要严格的测试、检验和认证 (TIC) 流程,以确保安全性和有效性。随着医疗设备业的不断发展,强大的 TIC 框架对于维护标准和保护病患健康至关重要。
市场限制
然而,该地区的医疗设备业受到严格且多方面的法规的约束,主要由美国食品药物管理局(FDA) 和加拿大卫生署强制执行。虽然这些法规结构旨在确保医疗设备的安全性、有效性和质量,但它们也给製造商和 TIC服务供应商带来了沉重的合规负担。为了应对这种复杂性,像 Stryker 这样的公司正在采用混合 TIC 策略,在内部维护关键的合规职能,同时将标准化测试程序外包给具有 FDA 和 MDSAP 记录的可信赖供应商。虽然这种方法有助于降低风险,但它限制了完全外包模式带来的规模和效率优势。
价值链分析
医疗设备测试、检验和认证外包市场价值链始于市场和监管情报,收集关于不断发展的标准和合规要求的关键数据。然后,提供测试和检验服务,严格评估器械的安全性、品质和功能性。认证工作则确保监管机构正式核准器材上市。咨询和计划管理在整个合规生命週期中提供策略支援。上市后,报告和数据分析提供性能洞察,为上市后监督和再认证提供信息,确保持续安全。最后,持续的创新和培训推动产品改进,并将这些改进反馈到市场和监管情报中。
服务展望
根据服务,市场分为测试、检验和认证。
1. 测试部分
测试部门对医疗设备进行严格评估,确保其在上市前符合适用的安全、性能和品质标准。这包括生物相容性测试、电磁相容性 (EMC) 测试、电气安全测试、机械测试、无菌测试以及软体驱动设备的软体检验。植入和穿戴式装置等复杂微型装置的日益普及,对广泛的第三方测试的需求也随之增加。
例如,Intertek Group plc 已将穿戴式生物感测器和医疗设备软体 (SaMD) 的先进测试纳入其服务组合,特别注重符合 IEC 62304 和 ISO 14971。同样,Eurofins Scientific SE 正在满足根据 ISO 10993 指南进行微生物学和化学性质测试日益增长的需求,这对于新型植入产品的临床前安全性评估至关重要。
2. 检查环节
测试服务提供实体和程序检验,以确保设备及其製造流程符合预先定义的规范和法规要求。这包括品管检验、进程内审核和最终产品检验,以便在产品上市前检测出偏差、缺陷或安全隐患。测试服务对于管理外包和全球製造相关的风险至关重要。
TUV SUD 和 UL Solutions 等主要企业提供现场和远端检验服务,尤其针对生产用于出口的 II 类和 III 类设备的亚洲工厂。 2023 年,必维国际检验集团与多家欧洲原始设备製造商合作,实施了远端工厂检验通讯协定,确保在供应链短缺和疫情相关的旅行限制等中断期间业务永续营运。这项创新凸显了远端检验技术日益普及的趋势。
设备类别展望
根据设备类别,市场分为 II 类、III 类和 I 类。
I类设备
一类医疗设备被认为风险较低,通常监管审查最少。例如压舌板、体温计、绷带和手动手术器械。这些器械通常不需要上市前核准或广泛的第三方测试,但品质检验和基本合规认证(例如 ISO 13485)仍然至关重要,尤其是在出口方面。
虽然TIC服务范围较窄,但Intertek和SGS等大型TIC公司为I类器材製造商提供批次检验、标籤检验和良好生产规范(GMP)审核。 2023年,UL Solutions为寻求进入欧盟和拉丁美洲市场的小型I类器械製造商推出了一项加速合规服务,这些市场对特定语言标籤和包装的审查日益严格。
Ⅱ类设备
第二类器械风险中等,需要更严格的监督。这些器械包括输液帮浦、电动轮椅、妊娠检测套组和血压监测仪等。第二类器械通常需要在美国进行510(k)上市前备案,并在欧盟进行技术文件和合格评定。
由于设备数量众多且对性能测试、电磁相容性、生物相容性和软体检验的要求严格,此类别在 TIC 外包领域占据主导地位,Eurofins Scientific、TUV SUD 和 BSI Group 等 TIC 供应商正在扩展其基础设施以满足这一需求。
最终用途展望
根据最终用途,市场细分为医疗设备公司、製药和生物技术公司以及其他最终用途。
医疗设备公司
医疗设备製造商在TIC外包领域占据主导地位,到2024年将占约77.6%的市场。这种主导地位源自于企业迫切需要遵守不断发展的国际法规,确保产品安全和效能,并加速日益复杂的医疗器材的上市时间。美国FDA的21 CFR Part 820、欧盟MDR和ISO 13485等标准要求进行广泛的检验、文件和测试,而这些在内部管理通常需要耗费大量的资源。
Medtronic等主要企业已与 Intertek 合作,简化设备测试并获得全球监管核准。同样,波士顿科学公司也与 SGS 合作,为 II 类和 III 类设备提供端到端品质保证测试。德国莱茵 TÜV 集团扩大了与西门子医疗的合作,以支持欧盟 MDR 制度下的全面合格评定。这些案例反映出,领先的製造商正日益依赖外部 TIC(医疗设备产业委员会)的专业知识来维持合规性,同时将内部资源集中在创新上。
医疗设备测试是将创新设计转化为可靠、适销对路产品的关键环节。 TÜV南德意志集团凭藉其在医疗产品测试领域的专业知识,以及遍布全球的国际认可实验室和设施网络,提供一站式解决方案。
TÜV SÜD -医疗设备和体外诊断医疗设备部门
日期:2025年
製药和生物技术公司
此细分市场包括开发组合产品的公司,例如自动注射器和药物释放型植入,这些产品必须同时符合药品和医疗设备法规。儘管製药和生物技术公司在总投资成本 (TIC) 方面的支出小于纯医疗设备製造商,但它们仍然是整个市场的重要贡献者。
例如,辉瑞委託其生物製药输送系统的分析测试和法规咨询外包给SGS,从而加强了合规工作。此外,欧陆科技为生技公司提供从研发到上市后监测阶段的一体化TIC服务。由于这些产品面临双重法律规范,TIC外包已成为确保全球应对力的一种颇具吸引力的策略。
“与临床试验专家合作有助于美国有效地应对医疗设备开发的复杂性,确保合规性并加快产品上市时间。”
Sheila Mathias 博士 - Virpax Pharmaceuticals 首席科学官
日期:2025年1月31日
区域展望
本报告涵盖的地区包括北美、欧洲、亚太地区、拉丁美洲以及中东和非洲。欧洲地区预计在2024年占据医疗设备测试、检验和认证外包市场39%的收益占有率。该地区各国高度重视严格的合格评定和上市后监督,这大大促进了对外包合规服务的需求。许多欧洲公司倾向于与独立的测试实验室合作,以确保其产品符合统一的标准。该地区对病患安全、创新和医疗设备跨境贸易的日益关注,进一步推动了对专业第三方认证和检验服务的需求。
The Global Medical Device Testing, Inspection And Certification Outsourcing Market size is expected to reach $5.48 billion by 2032, rising at a market growth of 8.3% CAGR during the forecast period.
Key Highlights:
The global medical device testing, inspection, and certification (TIC) outsourcing market has evolved significantly over the past few decades, driven by the rapid advancement of medical technologies, heightened regulatory scrutiny, and the globalization of healthcare product distribution. Initially, many medical device manufacturers managed quality assurance and regulatory compliance processes internally. However, as the complexity and diversity of devices increased, and global health authorities like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan's PMDA implemented stringent compliance frameworks, outsourcing emerged as a strategic necessity.
Medical device companies began relying on third-party TIC service providers to ensure compliance with national and international standards, improve product quality, and accelerate time-to-market. This trend was also influenced by the growing demand for medical devices across geographies, which required manufacturers to meet varied regulatory requirements, thus turning to specialized providers with multi-jurisdictional expertise.
Over time, outsourcing TIC functions helped companies reduce costs, mitigate risk, and maintain focus on core competencies such as innovation and product development. Government health departments and notified bodies across the EU and North America have played pivotal roles in defining safety standards and testing protocols, reinforcing the need for independent verification and validation. As healthcare infrastructure expands in emerging economies and the digitization of medical devices continues, the reliance on TIC outsourcing has further intensified, creating a robust and evolving global market.
One of the dominant trends shaping the medical device TIC outsourcing market is the integration of advanced technologies into devices, which has created a pressing need for new testing capabilities. Devices incorporating AI algorithms for diagnostics, IoT sensors for remote monitoring, and software-driven therapeutic interventions must be tested for cybersecurity, data accuracy, and real-time functionality. Traditional testing methods fall short in evaluating these novel components, pushing TIC providers to invest in high-tech labs and digital capabilities to remain relevant.
Another major trend is the increasing importance of regulatory compliance, driven by global events such as product recalls and patient safety concerns. Regulatory bodies have raised the bar for quality assurance, making independent TIC services indispensable for companies aiming to secure and retain certifications such as FDA 510(k), CE marking, and ISO 13485. Compliance is no longer a one-time activity but an ongoing requirement, prompting continuous engagement with TIC providers throughout the product lifecycle.
Market Consolidation Analysis
The Global Medical Device TIC Market is undergoing notable transformation driven by regulatory stringency, globalization of healthcare supply chains, and rapid advancements in medical device technology. Testing, Inspection, and Certification (TIC) services ensure product safety, compliance, and reliability for both manufacturers and regulators. As these services become increasingly specialized, the market is gravitating toward consolidation, where a few multinational TIC providers dominate by offering integrated, scalable, and globally harmonized solutions. Market consolidation is shaped by various factors including innovation, regulatory burden, entry barriers, and international partnerships-all of which determine the distribution of market power and future growth trajectories.
1. Level of Innovation - ★★★★☆ (4/5)
Innovation in the medical device TIC market revolves around automation in testing, AI-driven diagnostics, and digital inspection systems. Companies like TUV SUD, SGS, and Intertek are introducing machine learning-based testing frameworks and digital twins for predictive validation, significantly enhancing test coverage and reducing cycle time.
Justification:
Innovation is dynamic but still primarily evolutionary rather than disruptive. Since core testing methodologies are tied to international standards, room for radical innovation is limited. However, innovations in process digitization and AI integration offer moderate competitive differentiation, giving mid-to-large players an edge while allowing room for tier-2 players to innovate locally.
Product Life Cycle Analysis:
The Product Life Cycle (PLC) framework helps in understanding the maturity, competitive dynamics, investment focus, and strategic planning of a particular industry. In the context of the Global Medical Device TIC (Testing, Inspection, and Certification) Market, the PLC analysis is instrumental for stakeholders to determine where the market currently stands, what challenges and opportunities exist at each stage, and how key players adapt to evolving regulatory, technological, and customer landscapes. This analysis combines historical evolution, present dynamics, and strategic movements by major TIC firms.
1. Introduction Stage
In the early 2000s, the medical device TIC outsourcing market began gaining traction as regulatory bodies like the U.S. FDA, the European Medicines Agency (EMA), and Japan's PMDA started tightening compliance and quality standards. The demand for third-party validation surged. During this period, TIC was still largely handled in-house by manufacturers. For example, TUV SUD and SGS were among the few global players offering independent services, but adoption was cautious due to data confidentiality concerns and underdeveloped outsourcing ecosystems.
During this stage, the market was characterized by low awareness, high customization, high service cost, and longer contract negotiation cycles. TIC companies had to educate OEMs about the benefits of independent validation.
2. Growth Stage
From around 2010 to 2020, the market entered a high-growth phase driven by several factors: expansion of global medical device exports, complex multi-country regulatory compliance needs (e.g., MDR in Europe), and the surge in novel devices such as implantables and wearables. A turning point was the implementation of the European Union Medical Device Regulation (EU MDR) in 2017, which heightened the need for robust testing and documentation.
Major players including Intertek, Bureau Veritas, and UL Solutions expanded services in Asia-Pacific and the Middle East to meet demand from OEMs seeking global market access. For instance, in 2019, SGS expanded its life sciences laboratory in Shanghai, enhancing its capacity for biocompatibility testing of Class II and III devices targeting international certification.
3. Maturity Stage
The Global Medical Device TIC Outsourcing Market is currently in the maturity stage. By 2024, the market has consolidated significantly, with companies such as TUV Rheinland, Eurofins Scientific, and SGS providing end-to-end services for product safety, cybersecurity certification, software validation, and more.
Testing accounted for approximately 65.1% of the market share in 2024, indicating a shift towards more standardized and repetitive service demand, particularly for regulatory compliance renewals and cybersecurity assessments for connected devices.
Recent examples include UL Solutions' 2023 partnership with Japan's NTT Data to develop a secure certification protocol for AI-driven diagnostic tools, and Intertek's 2022 acquisition of SAI Global Assurance to enhance its medical device vertical in North America.
4. Saturation and Early Decline
While the core TIC services are mature, saturation is expected in developed economies for traditional device segments. However, growth pockets remain in AI-integrated devices, robotic surgery systems, and personalized diagnostics. For instance, Bureau Veritas launched a smart health TIC initiative in 2023 targeting AI-based imaging tools and wearable sensors.
As TIC becomes commoditized, value-added services such as digital testing, remote inspections, and real-time compliance analytics will define future differentiation. But without innovation, service margins are likely to decline gradually.
5.Conclusion & Current Stage of the Market
Based on the above analysis, the Global Medical Device TIC Outsourcing Market is firmly in its maturity stage of the product life cycle. The market is characterized by strong demand, high service standardization, aggressive global expansion by leading players, and emerging innovations to avoid commoditization. Yet, due to regulatory tailwinds, technological evolution in devices, and rising cross-border trade, it still offers growth avenues in specialized service niches and underserved geographies.
COVID 19 Impact Analysis
The COVID-19 pandemic had a negative impact on the Medical Device Testing, Inspection, and Certification (TIC) Outsourcing Market. During the initial outbreak, global lockdowns and supply chain disruptions delayed manufacturing and testing operations. Many non-essential and elective medical devices saw reduced production, leading to a decline in demand for TIC services. Additionally, restrictions on physical audits and site inspections hampered certification processes. Thus, the COVID-19 pandemic had a negative impact on the market during its early phases.
Market Growth Factors
One of the most prominent examples of this trend is the surge in AI-enabled medical devices entering the North American market. As of August 2024, the FDA had authorized 950 AI- or machine learning-enabled medical devices, up from only a few dozen in early 2020. This exponential increase reflects both the growing role of digital technologies in healthcare and the FDA's evolving regulatory approach to autonomous and semi-autonomous decision-support tools. This has created new demand for TIC vendors that offer post-market surveillance, real-world evidence (RWE) collection, and software lifecycle auditing.
Additionally, Rapid technological advancements are significantly transforming the medical device landscape in North America, driving innovation and reshaping patient care. These developments are not only enhancing diagnostic and therapeutic capabilities but also necessitating rigorous Testing, Inspection, and Certification (TIC) processes to ensure safety and efficacy. As the medical device industry continues to evolve, robust TIC frameworks will be essential to uphold standards and protect patient well-being.
Market Restraining Factors
However, the medical device industry in this region is bound by rigorous and multifaceted regulations, primarily enforced by the U.S. Food and Drug Administration (FDA) and Health Canada. These regulatory frameworks are designed to ensure the safety, efficacy, and quality of medical devices but also create a substantial compliance burden for manufacturers and TIC service providers. In response to these complexities, companies like Stryker Corporation have adopted hybrid TIC strategies-keeping critical compliance functions in-house while outsourcing standardized testing procedures to trusted vendors with proven FDA and MDSAP experience. While this approach helps mitigate risks, it limits the scale and efficiency benefits typically associated with full outsourcing models.
Value Chain Analysis
The value chain of the Medical Device Testing, Inspection, and Certification Outsourcing Market begins with Market & Regulatory Intelligence, where critical data on evolving standards and compliance requirements is gathered. This is followed by Test & Inspection Services, which involve rigorous evaluation of device safety, quality, and functionality. Next, Certification Engagement ensures regulatory bodies formally approve devices for market access. Advisory & Project Management provides strategic support throughout the compliance lifecycle. Post-launch, Reporting & Data Analytics delivers performance insights, feeding into Post-Market Surveillance & Recertification to ensure ongoing safety. Finally, Continuous Innovation & Training fosters product improvements, feeding back into Market & Regulatory Intelligence.
Service Outlook
Based on Service, the market is segmented into Testing, Inspection, and Certification.
1. Testing Segment
The Testing segment involves rigorous evaluations of medical devices to ensure they meet applicable safety, performance, and quality standards before they are launched in the market. This includes biocompatibility tests, electromagnetic compatibility (EMC) tests, electrical safety testing, mechanical testing, sterility testing, and software validation for software-driven devices. The increasing prevalence of complex and miniaturized devices, such as implantables and wearables, has driven the need for extensive third-party testing.
For instance, Intertek Group plc has expanded its service portfolio to include advanced testing for wearable biosensors and software as a medical device (SaMD), particularly focusing on IEC 62304 and ISO 14971 compliance. Similarly, Eurofins Scientific SE has seen increasing demand for microbiology and chemical characterization testing under ISO 10993 guidelines, critical for preclinical safety assessments of new implantable products.
2. Inspection Segment
The Inspection service involves physical and procedural verification of devices and their production processes to ensure they meet predefined specifications and regulatory requirements. These include quality control inspections, in-process audits, and final product verification to detect deviations, defects, or safety concerns before market release. Inspection services are vital in managing risks associated with outsourced and global manufacturing.
Key players like TUV SUD and UL Solutions offer both onsite and remote inspections, particularly for facilities in Asia that manufacture Class II and Class III devices for export. In 2023, Bureau Veritas partnered with multiple OEMs across Europe to implement remote factory inspection protocols, enabling business continuity during disruptions like supply chain shortages and pandemic-related travel restrictions. This innovation underscores how remote inspection technology is becoming more mainstream.
Device Class Outlook
Based on Device Class, the market is segmented into Class II, Class III, and Class I.
Class I Devices
Class I medical devices are considered low-risk and generally subject to the least regulatory scrutiny. Examples include tongue depressors, thermometers, bandages, and manual surgical instruments. These devices typically do not require premarket approval or extensive third-party testing, but quality inspections and basic compliance certification (e.g., ISO 13485) are still critical, especially for export.
Although the scope of TIC services is narrower, leading TIC players like Intertek and SGS provide batch inspection, label verification, and good manufacturing practice (GMP) audits for Class I device producers. In a 2023 development, UL Solutions launched a fast-track compliance service aimed at small-scale Class I device manufacturers looking to enter EU and Latin American markets, where language-specific labeling and packaging reviews are becoming more stringent.
Class II Devices
Class II devices pose moderate risk and require more robust oversight. These include devices such as infusion pumps, powered wheelchairs, pregnancy test kits, and blood pressure monitors. Class II devices typically require 510(k) premarket notification in the U.S. or technical documentation and conformity assessments in the EU.
This category dominates the TIC outsourcing landscape due to the volume of devices, coupled with stringent requirements around performance testing, electromagnetic compatibility, biocompatibility, and software validation. TIC providers like Eurofins Scientific, TUV SUD, and BSI Group have expanded their infrastructure to meet this demand.
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
Medical device manufacturers dominate the TIC outsourcing landscape, accounting for approximately 77.6% of the total market share in 2024. This prominence is driven by their critical need to align with evolving international regulations, ensure safety and performance of products, and speed up time-to-market for increasingly complex devices. Standards like the U.S. FDA's 21 CFR Part 820, EU MDR, and ISO 13485 require extensive validation, documentation, and testing-activities which are often resource-intensive to manage internally.
Leading companies like Medtronic have partnered with Intertek to facilitate device testing and meet global regulatory approvals more efficiently. Similarly, Boston Scientific engages with SGS for end-to-end quality assurance testing for its Class II and III devices. TUV Rheinland has expanded its collaboration with Siemens Healthineers, supporting full-scope conformity assessments under the EU MDR regime. These examples reflect how large manufacturers increasingly rely on external TIC expertise to maintain compliance while focusing internal resources on innovation.
"Medical device testing is a critical step in the process of transforming an innovative design into a reliable and marketable product. At TUV SUD, we combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing you with a one-stop solution."
TUV SUD - Medical Devices and IVD Division
Date: 2025
Pharmaceutical and Biotech Companies
This segment includes firms developing combination products, such as autoinjectors or drug-eluting implants, which must meet both pharmaceutical and medical device regulations. Though smaller than pure-play device firms in terms of TIC spending, pharmaceutical and biotech companies are important contributors to the overall market.
Pfizer, for example, has strengthened its compliance efforts by engaging SGS to oversee analytical testing and regulatory consulting for its biologics delivery systems. Additionally, Eurofins Scientific supports biotech firms by offering integrated TIC services for their products across development and post-market surveillance stages. The dual regulatory oversight these products face makes TIC outsourcing an attractive strategy for ensuring global readiness.
"Collaborating with specialized partners in clinical trials allows us to navigate the complexities of medical device development efficiently, ensuring compliance and accelerating time-to-market."
Dr. Sheila Mathias - Chief Scientific Officer, Virpax Pharmaceuticals
Date: January 31, 2025
Region Outlook
The geographies included in the report are North America, Europe, Asia Pacific, and Latin America, Middle East & Africa. The Europe segment witnessed 39% revenue share in the Medical Device Testing, Inspection And Certification Outsourcing Market in 2024. Countries across the region emphasize stringent conformity assessments and post-market surveillance, which significantly contributes to the demand for outsourced compliance services. Many European companies prefer to engage independent testing laboratories to ensure that their products meet harmonized standards. The region's growing focus on patient safety, innovation, and cross-border trade of medical devices further fuels the need for expert third-party certification and inspection services.
List of Key Companies Profiled
Global Medical Device Testing, Inspection And Certification Outsourcing Market Report Segmentation
By Service
By Device Class
By End Use
By Geography