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Global Medical Device Safety Testing Industry Outlook 2025-2029: Market Set to Cross $12.96 Billion Milestone

11-21-2025 08:44 AM CET | Health & Medicine

Press release from: The Business Research Company

Medical Device Safety Testing

Medical Device Safety Testing

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How Large Will the Medical Device Safety Testing Market Size By 2025?
The safety evaluation sector for medical apparatus has experienced robust expansion recently, projected to increase its valuation from $8.55 billion in 2024 up to $9.29 billion by 2025, reflecting an annual growth trajectory of 8.6% compounded over the period. This past expansion was fueled by several factors including the mounting intricacy of the devices, a higher frequency of product withdrawals from the market, stricter compliance mandates, the worldwide nature of medical equipment production, and more frequent regulatory oversight reviews.

How Big Is the Medical Device Safety Testing Market Size Expected to Grow by 2029?
Projected for a robust expansion, the medical device safety testing sector anticipates significant upward momentum in the coming years, reaching a market valuation of $12.96 billion by 2029, driven by an 8.7% compound annual growth rate; this expansion throughout the projection span is fueled by several factors, notably the proliferation of devices both worn and implanted, the ongoing alignment of international regulatory standards, the enforcement of sustainability and ecological mandates, the increasing adoption of remote testing methodologies and virtual modeling, and the growth observed within regulatory advisory services, while key developments shaping this period involve predictive testing powered by artificial intelligence, the emergence of digital twin concepts, enhanced focus on cybersecurity and embedded software validation, the development of specialized testing protocols for wearables, and testing related to fifth generation wireless technology and signal interference.

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Which Key Market Drivers Powering Medical Device Safety Testing Market Expansion and Growth?
Anticipated expansion in the medical device safety testing sector is likely to be fueled by the rising prevalence of ailments linked to daily living patterns, such as cardiovascular issues, obesity, hypertension, certain malignancies, and psychological conditions, all stemming from individual behaviors. This surge in lifestyle-associated conditions, often linked to insufficient physical activity resulting in weight gain and decreased heart and insulin function, consequently heightens the threat of long-term illnesses. Safety assessments for medical apparatus are crucial in managing these conditions by confirming the dependable operation and accurate function of tools used for both diagnosis and therapy, thereby safeguarding patients and optimizing treatment results as devices are validated against established compliance benchmarks, fostering greater confidence and streamlined efficacy within contemporary medical practice. To illustrate this escalating trend, official figures from the United Kingdom's National Health Service in June 2024 showed that registered general practitioner patients diagnosed with non-diabetic hyperglycemia or pre-diabetes climbed to 3,615,330 in 2023, a discernible 18 percent jump from the 3,065,825 diagnoses recorded the previous year in 2022, directly emphasizing how the growing burden of these lifestyle diseases necessitates greater demand for the safety verification of medical technologies.

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Which Fast-Growing Trends Are Poised to Disrupt the Medical Device Safety Testing Market?
Leading enterprises within the medical device safety evaluation sector are prioritizing growth by implementing sophisticated technical offerings, including cutting-edge medical device testing infrastructures, aiming to boost precision in assessments, shorten the duration until market availability, and adhere to shifting worldwide regulatory mandates. Such a sophisticated medical device testing establishment is defined as a dedicated facility or unit outfitted with the newest equipment and specialized knowledge necessary for thorough examination and appraisal of medical apparatus. To illustrate, in the closing stages of 2023, Impelsys, an organization originating from India, inaugurated a modernized facility for medical device testing located in Mangalore, India; this laboratory utilizes analytical methods powered by artificial intelligence alongside web-hosted systems to speed up progress on diagnostic and treatment devices via superior testing procedures, modeling, and help navigating regulations, thereby highlighting their dedication to fostering healthcare advancements based on empirical data.

What Are the Emerging Segments in the Medical Device Safety Testing Market?
The medical device safety testingmarket covered in this report is segmented -

1) By Service Type: Testing; Inspection; Certification
2) By Testing Phase: Preclinical Testing; Clinical Testing
3) By Technology: Active Implantable Devices; In Vitro Diagnostic Devices; Diagnostic Imaging Devices; Ophthalmic Devices
4) By Application: Cardiovascular Devices; Orthopedic Devices; Neurological Devices; Ophthalmic Devices; Dental Devices
5) By End User: Hospitals; Clinics; Research Laboratories; Medical Device Manufacturers; Regulatory Bodies

Subsegments:
1) By Testing: Electrical Safety Testing; Electromagnetic Compatibility (EMC) Testing; Biocompatibility Testing; Environmental Testing; Mechanical Safety Testing; Performance Testing; Software Validation Testing; Chemical Characterization Testing
2) By Inspection: Pre-Market Inspection; In-Process Inspection; Final Product Inspection; Supplier Audit and Evaluation; Manufacturing Site Inspection; Quality System Inspection
3) By Certification: International Organization for Standardization (ISO) 13485 Certification; Conformité Européenne (CE) Marking; Food and Drug Administration (FDA) Premarket Approval (PMA) Support; Medical Device Single Audit Program (MDSAP) Certification; International Electrotechnical Commission (IEC) 60601 Certification; European Union (EU) Medical Device Regulation (MDR) Compliance Certification; Product Safety Certification

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Who Are the Global Leaders in the Medical Device Safety Testing Market?
Major companies operating in the medical device safety testing market are Thermo Fisher Scientific, Medtronic plc, Baxter International, SGS SA, Eurofins Scientific SE, Bureau Veritas SA, Bausch & Lomb, Intertek Group plc, TÜV SÜD AG, Underwriters Laboratories LLC, Applus+ Group, BSI Group , NSF International , NEMKO AS, Smithers Group Inc., Laboratory Testing Inc., JPen Medical Inc., ArchiMed, F2 Labs Inc., Medistri SA

Which are the Top Profitable Regional Markets for the Medical Device Safety Testing Industry?
North America was the largest region in the medical device safety testing market in 2024. Asia-Pacific is expected to be the highest-growing region in the forecast period. The regions covered in the medical device safety testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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With over 17500+ reports from 27 industries covering 60+ geographies, The Business Research Company has built a reputation for offering comprehensive, data-rich research and insights. Armed with 1,500,000 datasets, the optimistic contribution of in-depth secondary research, and unique insights from industry leaders, you can get the information you need to stay ahead.Our flagship product, the Global Market Model (GMM), is a premier market intelligence platform delivering comprehensive and updated forecasts to support informed decision-making.

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