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市場調查報告書
商品編碼
1785249
全球醫療設備測試、檢驗和認證外包市場規模、佔有率和行業分析報告(按服務、設備類別、最終用途和地區、展望和預測,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 |
預計到 2032 年,醫療設備測試、檢驗和認證外包市場規模將達到 54.8 億美元,預測期內的複合年成長率為 8.3%。
主要亮點:
過去幾十年來,受醫療技術快速發展、監管審查力度加大以及醫療保健產品分銷全球化的推動,醫療設備測試、檢驗和認證 (TIC) 外包市場發生了顯著變化。最初,許多醫療設備製造商在內部管理其品質保證和法規合規流程。然而,隨著器械複雜性和多樣性的增加,以及美國食品藥物管理局(FDA)、歐洲藥品管理局 (EMA) 和日本醫療器材製造商協會 (PMDA) 等全球衛生機構實施嚴格的合規框架,外包成為一種策略必需。
醫療設備公司開始更依賴第三方TIC服務供應商來遵守國內和國際標準,提高產品品質,並加快上市時間。跨區域醫療設備需求的成長也推動了這一趨勢,迫使製造商滿足多樣化的監管要求,並轉向在多個司法管轄區擁有專業知識的專業服務提供者。
隨著時間的推移,TIC 職能外包有助於企業降低成本、規避風險,並專注於創新和產品開發等核心競爭力。歐盟和北美的政府衛生機構和認證機構在製定安全標準和測試通訊協定方面發揮關鍵作用,這進一步強化了獨立檢驗和確認的必要性。新興國家醫療基礎設施的擴張以及醫療設備數位化的日益發展將進一步增加對 TIC 外包的依賴,從而創造一個蓬勃發展且不斷發展的全球市場。
影響醫療設備TIC外包市場的關鍵趨勢之一是先進技術與設備的整合,這迫切需要新的測試能力。整合了用於診斷的AI演算法、用於遠端監控的物聯網感測器以及軟體驅動的治療性介入的設備需要進行網路安全、數據準確性和即時功能測試。傳統的測試方法不足以評估這些新組件,迫使TIC供應商投資高科技實驗室和數位化能力,以保持競爭力。
另一個主要趨勢是,受產品召回和病人安全問題等全球性事件的推動,合規性的重要性日益提升。監管機構正在提高品質保證的標準,這使得獨立的TIC服務對於尋求獲得並維持FDA 510(k)、CE標誌和ISO 13485等認證的公司至關重要。合規性不再是一次性活動,而是一項持續的要求,需要在整個產品生命週期中與您的TIC提供者持續合作。
市場整合分析
由於法規日益嚴格、醫療供應鏈全球化以及醫療設備技術的快速發展,全球醫療設備TIC市場正經歷重大變革時期。測試、檢驗和認證 (TIC) 服務確保製造商和監管機構的產品安全性、合規性和可靠性。隨著這些服務日益專業化,市場正在整合,少數跨國TIC供應商透過提供整合、擴充性且全球協調的解決方案佔據主導地位。市場整合受到多種因素的影響,包括創新、監管負擔、進入障礙和國際夥伴關係關係,所有這些因素都將決定市場力量的分配和未來的成長軌跡。
1. 創新程度-★★★★☆(4/5)
醫療設備TIC市場的創新圍繞著測試自動化、人工智慧診斷和數位檢測系統。 TUV SUD、SGS和Intertek等公司正在實施基於機器學習的測試框架和數位雙胞胎,用於預測檢驗,從而顯著擴展測試範圍並縮短測試週期。
基礎:
創新是動態的,但它是漸進式的,而非顛覆性的。核心測試方法與國際標準息息相關,限制了徹底創新的空間。然而,流程數位化和人工智慧整合的創新提供了適度的競爭差異化,使中型和大型企業獲得優勢,同時也為二級企業留下了在地化創新的空間。
產品生命週期分析:
產品生命週期 (PLC) 框架有助於了解特定產業的成熟度、競爭趨勢、投資重點和策略規劃。在全球醫療設備TIC(測試、檢驗和認證)市場中,PLC 分析可幫助相關人員了解市場現狀、每個階段的挑戰和機會,以及主要企業如何適應不斷變化的監管、技術和客戶環境。該分析整合了 TIC 主要參與者的過往發展、當前趨勢和策略舉措。
1. 引入階段
21世紀初,隨著美國食品藥物管理局 (FDA)、歐洲藥品管理局 (EMA) 和日本藥品管理局 (PMDA) 等監管機構開始加強合規性和品質標準,醫療設備TIC外包市場開始蓬勃發展。第三方驗證的需求激增。在此期間,TIC仍然主要由製造商內部處理。儘管TUV SUD和SGS是少數幾家提供獨立服務的全球公司之一,但由於對資料隱私和外包生態系統不發達的擔憂,人們對採用這些服務持謹慎態度。
此階段市場認知度較低、客製化程度高、服務成本高、合約談判週期長,TIC公司需要向OEM廠商宣傳獨立檢驗的優勢。
2. 成長階段
2010年至2020年左右,醫療器材市場進入快速成長期,推動因素包括全球醫療設備出口擴張、遵守多國複雜法規(例如歐洲醫療器材法規 (MDR))的需求,以及植入和穿戴式裝置等新型設備的激增。 2017年生效的《歐盟醫療設備法規》(EU MDR) 為醫療器材市場帶來了轉捩點,它增加了對嚴格測試和記錄的需求。
Intertek、必維國際檢驗集團 (Bureau Veritas) 和 UL Solutions 等領先公司已擴展其在亞太地區和中東地區的服務,以滿足原始設備製造商 (OEM) 對全球市場准入的需求。例如,SGS 於 2019 年擴建了其位於上海的生命科學實驗室,以增強其針對 II 類和 III 類醫療器材的生物相容性測試能力,從而獲得國際認證。
3.成熟階段
全球醫療設備TIC外包市場目前正處於成熟階段。至2024年,市場將實現顯著整合,屆時TUV Rheinland、Eurofins Scientific和SGS等公司將提供產品安全、網路安全認證、軟體檢驗等端到端服務。
預計到 2024 年,測試將佔據約 65.1% 的市場佔有率,需求將轉向更標準化和重複性的服務,特別是在法規合規性更新和連接設備的網路安全評估方面。
最近的例子包括 UL Solutions 於 2023 年與日本 NTT Data 合作開發用於人工智慧診斷工具的安全認證通訊協定,Intertek 於 2022 年收購 SAI Global Assurance 以加強其北美醫療設備部門。
4. 飽和與早期衰退
儘管核心TIC服務已經成熟,但傳統設備領域預計在已開發國家將達到飽和。然而,人工智慧整合設備、機器人手術系統和個人化診斷仍有成長空間。例如,必維國際檢驗集團於2023年推出了其智慧健康TIC舉措,目標是基於人工智慧的診斷成像工具和穿戴式感測器。
隨著 TIC 成為一種商品,數位測試、遠端檢查和即時合規分析等附加價值服務將決定未來的差異化,但如果沒有創新,服務利潤率將逐漸下降。
5. 結論與市場現狀
基於上述分析,全球醫療設備TIC外包市場正處於其產品生命週期的成熟階段。該市場的特點是需求強勁、服務標準化程度高、主要企業積極進行全球擴張,以及為避免商品化而不斷創新。然而,由於監管順風順水、設備技術進步以及跨境貿易成長,專業領域和服務匱乏的地區仍有成長空間。
COVID-19影響分析
新冠疫情對醫療設備測試、檢驗和認證 (TIC) 外包市場產生了負面影響。最初,全球封鎖和供應鏈中斷導致製造和測試業務延遲。許多非必需和非必需醫療設備醫療設備的產量下降,從而降低了對 TIC 服務的需求。此外,現場審核和檢驗的限制也擾亂了認證流程。因此,新冠疫情在初期就對市場產生了負面影響。
市場成長要素
這一趨勢最引人注目的例子之一是人工智慧醫療設備在北美市場的激增。截至2024年8月,FDA已核准了950種支援人工智慧或機器學習的醫療設備,較2020年初的數十種大幅成長。這種快速成長反映了數位科技在醫療保健領域日益成長的作用,以及FDA對自主和半自動決策支援工具不斷變化的監管方法。這為提供上市後監測、真實世界證據(RWE)收集和軟體生命週期審核的TIC供應商創造了新的需求。
此外,快速的技術進步正在顯著改變北美醫療設備格局,推動創新並重塑患者照護。這些進步不僅提高了診斷和治療能力,還需要嚴格的測試、檢驗和認證 (TIC) 流程,以確保安全性和有效性。隨著醫療設備業的不斷發展,強大的 TIC 框架對於維護標準和保護病患健康至關重要。
市場限制
然而,該地區的醫療設備業受到嚴格且多方面的法規的約束,主要由美國食品藥物管理局(FDA) 和加拿大衛生署強制執行。雖然這些法規結構旨在確保醫療設備的安全性、有效性和質量,但它們也給製造商和 TIC服務供應商帶來了沉重的合規負擔。為了應對這種複雜性,像 Stryker 這樣的公司正在採用混合 TIC 策略,在內部維護關鍵的合規職能,同時將標準化測試程序外包給具有 FDA 和 MDSAP 記錄的可信賴供應商。雖然這種方法有助於降低風險,但它限制了完全外包模式帶來的規模和效率優勢。
價值鏈分析
醫療設備測試、檢驗和認證外包市場價值鏈始於市場和監管情報,收集關於不斷發展的標準和合規要求的關鍵數據。然後,提供測試和檢驗服務,嚴格評估器械的安全性、品質和功能性。認證工作則確保監管機構正式核准器材上市。諮詢和計劃管理在整個合規生命週期中提供策略支援。上市後,報告和數據分析提供性能洞察,為上市後監督和再認證提供資訊,確保持續安全。最後,持續的創新和培訓推動產品改進,並將這些改進反饋到市場和監管情報中。
服務展望
根據服務,市場分為測試、檢驗和認證。
1. 測試部分
測試部門對醫療設備進行嚴格評估,確保其在上市前符合適用的安全、性能和品質標準。這包括生物相容性測試、電磁相容性 (EMC) 測試、電氣安全測試、機械測試、無菌測試以及軟體驅動設備的軟體檢驗。植入和穿戴式裝置等複雜微型裝置的日益普及,對廣泛的第三方測試的需求也隨之增加。
例如,Intertek Group plc 已將穿戴式生物感測器和醫療設備軟體 (SaMD) 的先進測試納入其服務組合,特別注重符合 IEC 62304 和 ISO 14971。同樣,Eurofins Scientific SE 正在滿足根據 ISO 10993 指南進行微生物學和化學性質測試日益成長的需求,這對於新型植入產品的臨床前安全性評估至關重要。
2. 檢查環節
測試服務提供實體和程序檢驗,以確保設備及其製造流程符合預先定義的規範和法規要求。這包括品管檢驗、進程內審核和最終產品檢驗,以便在產品上市前檢測出偏差、缺陷或安全隱患。測試服務對於管理外包和全球製造相關的風險至關重要。
TUV SUD 和 UL Solutions 等主要企業提供現場和遠端檢驗服務,尤其針對生產用於出口的 II 類和 III 類設備的亞洲工廠。 2023 年,必維國際檢驗集團與多家歐洲原始設備製造商合作,實施了遠端工廠檢驗通訊協定,確保在供應鏈短缺和疫情相關的旅行限制等中斷期間業務永續營運。這項創新凸顯了遠端檢驗技術日益普及的趨勢。
設備類別展望
根據設備類別,市場分為 II 類、III 類和 I 類。
I類設備
一類醫療設備被認為風險較低,通常監管審查最少。例如壓舌板、體溫計、繃帶和手動手術器械。這些器械通常不需要上市前核准或廣泛的第三方測試,但品質檢驗和基本合規認證(例如 ISO 13485)仍然至關重要,尤其是在出口方面。
雖然TIC服務範圍較窄,但Intertek和SGS等大型TIC公司為I類器材製造商提供批次檢驗、標籤檢驗和良好生產規範(GMP)審核。 2023年,UL Solutions為尋求進入歐盟和拉丁美洲市場的小型I類器械製造商推出了一項加速合規服務,這些市場對特定語言標籤和包裝的審查日益嚴格。
Ⅱ類設備
第二類器械風險中等,需要更嚴格的監督。這些器械包括輸液幫浦、電動輪椅、妊娠檢測套組和血壓監測儀等。第二類器械通常需要在美國進行510(k)上市前備案,並在歐盟進行技術文件和合格評定。
由於設備數量眾多且對性能測試、電磁相容性、生物相容性和軟體檢驗的要求嚴格,此類別在 TIC 外包領域佔據主導地位,Eurofins Scientific、TUV SUD 和 BSI Group 等 TIC 供應商正在擴展其基礎設施以滿足這一需求。
最終用途展望
根據最終用途,市場細分為醫療設備公司、製藥和生物技術公司以及其他最終用途。
醫療設備公司
醫療設備製造商在TIC外包領域佔據主導地位,到2024年將佔約77.6%的市場。這種主導地位源自於企業迫切需要遵守不斷發展的國際法規,確保產品安全和效能,並加速日益複雜的醫療器材的上市時間。美國FDA的21 CFR Part 820、歐盟MDR和ISO 13485等標準要求進行廣泛的檢驗、文件和測試,而這些在內部管理通常需要耗費大量的資源。
Medtronic等主要企業已與 Intertek 合作,簡化設備測試並獲得全球監管核准。同樣,波士頓科學公司也與 SGS 合作,為 II 類和 III 類設備提供端到端品質保證測試。德國萊茵 TÜV 集團擴大了與西門子醫療的合作,以支持歐盟 MDR 制度下的全面合格評定。這些案例反映出,領先的製造商正日益依賴外部 TIC(醫療設備產業委員會)的專業知識來維持合規性,同時將內部資源集中在創新上。
醫療設備測試是將創新設計轉化為可靠、適銷對路產品的關鍵環節。 TÜV南德意志集團憑藉其在醫療產品測試領域的專業知識,以及遍佈全球的國際認可實驗室和設施網路,提供一站式解決方案。
TÜV SÜD -醫療設備和體外診斷醫療設備部門
日期:2025年
製藥和生物技術公司
此細分市場包括開發組合產品的公司,例如自動注射器和藥物釋放型植入,這些產品必須同時符合藥品和醫療設備法規。儘管製藥和生物技術公司在總投資成本 (TIC) 方面的支出小於純醫療設備製造商,但它們仍然是整個市場的重要貢獻者。
例如,輝瑞委託其生物製藥輸送系統的分析測試和法規諮詢外包給SGS,從而加強了合規工作。此外,歐陸科技為生技公司提供從研發到上市後監測階段的一體化TIC服務。由於這些產品面臨雙重法律規範,TIC外包已成為確保全球應對力的一種頗具吸引力的策略。
“與臨床試驗專家合作有助於美國有效地應對醫療設備開發的複雜性,確保合規性並加快產品上市時間。”
Sheila Mathias 博士 - Virpax Pharmaceuticals 首席科學官
日期:2025年1月31日
區域展望
本報告涵蓋的地區包括北美、歐洲、亞太地區、拉丁美洲以及中東和非洲。歐洲地區預計在2024年佔據醫療設備測試、檢驗和認證外包市場39%的收益佔有率。該地區各國高度重視嚴格的合格評定和上市後監督,這大大促進了對外包合規服務的需求。許多歐洲公司傾向於與獨立的測試實驗室合作,以確保其產品符合統一的標準。該地區對病患安全、創新和醫療設備跨境貿易的日益關注,進一步推動了對專業第三方認證和檢驗服務的需求。
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