United States Medical Device Testing And Certification Market Size & Outlook, 2025-2031
United States Medical Device Testing And Certification Market Size
According to Straits Research analysis, the United States Medical Device Testing and Certification Market was valued at USD 3815.68 Million in 2024 and is projected to reach USD 5160.85 Million by 2031, expanding at a CAGR of 4.4% during the forecast period. The rising demand for high-quality medical devices, especially in sectors such as diagnostics, therapeutics, and patient monitoring, is propelling market growth. Strict regulatory standards and guidelines that ensure device safety and effectiveness are also key factors driving the market. Emerging trends such as technological advancements in testing and certification methods, as well as the potential for exporting certified devices to international markets, offer opportune scenarios for market expansion. Significant investments in research and development reaffirm the U.S's commitment to secure its lead in the medical device testing and certification market.
Source: Straits Research Analysis Company Publications, Primary Interviews.
United States Medical Device Testing And Certification Market Highlights
- By 2024, Testing Services represented the largest share of the Service Type market size.
- Certification Services is expected to remain the key growth driver within Service Type, registering the fastest CAGR during the forecast period.
- As of 2024, United States held 37.89% of the global medical device testing and certification market size.
- By 2031, United States is anticipated to capture the largest share of the global medical device testing and certification market.
- In North America, United States is expected to lead the regional medical device testing and certification market size by 2031.
- Canada will remain the fastest-growing market in North America, reaching USD 735.73 Million by 2031.
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Report Summary
| Report Scope | Details |
|---|---|
| Base Year for Study | 2024 |
| Study Period | 2021-2031 |
| Historical Period | 2021-2023 |
| Forecast Period | 2025-2031 |
| Market Size In 2024 | USD 3815.68 Million |
| Market Size In 2031 | USD 5160.85 Million |
| Largest segment | Testing Services |
| Fastest segment | Certification Services |
| Units | Revenue in USD Million |
| CAGR | 4.4% (2025-2031) |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends |
United States Medical Device Testing And Certification Market Share By Service Type
Segmentation Covered
| Segments | Sub Segments |
|---|---|
| Service Type |
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| Sourcing Type |
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| Device Class |
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| Technology |
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United States Medical Device Testing And Certification Market By Service Type 2031
Source: Straits Research Analysis Company Publications, Primary Interviews.
United States Medical Device Testing And Certification Market By Sourcing Type 2031
Source: Straits Research Analysis Company Publications, Primary Interviews.
United States Medical Device Testing And Certification Market By Device Class 2031
Source: Straits Research Analysis Company Publications, Primary Interviews.
United States Medical Device Testing And Certification Market By Technology 2031
Source: Straits Research Analysis Company Publications, Primary Interviews.
