The medical device testing market provides services to ensure that medical devices meet regulatory standards and are safe and effective for their intended use. This market includes testing laboratories, certification bodies, and other service providers that offer a range of services such as product testing, quality assurance, compliance testing, and regulatory consulting. The market is driven by increasing regulatory requirements for medical devices, a growing need for product safety and efficacy, and the increasing complexity of medical devices. Regulatory bodies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national agencies require extensive testing and documentation to ensure that medical devices meet safety and efficacy standards before they can be marketed and sold to healthcare providers and patients.

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According to UnivDatos Market Insights (UMI)’ research report “Global Medical device testing Market”, the market is expected to witness robust growth during the forecast period (2022-2028).

Based on the service type, the market has been categorized into testing services, inspection services, and certification services. Among them, the certification services segment is expected to grow at the highest CAGR in the market. Certification services are another crucial service type in the medical device testing market. Certification services involve the assessment of medical devices against regulatory standards to ensure that they meet safety and efficacy requirements. Certification is necessary for medical device manufacturers to obtain regulatory approval and bring their products to market.

Based on the testing type, the market has been categorized into physical testing, chemical/biological testing, cybersecurity testing, microbiology & sterility testing, and others. Among them, the chemical/biological testing segment holds a significant share of the market in terms of testing type due to its critical role in assessing the compatibility of medical devices with the human body. This type of testing is critical because medical devices often come into contact with body tissues or fluids and can cause harm if they are not compatible with the human body.

North America to witness extensive growth

For a better understanding of the market adoption of the medical device testing industry, the market is analyzed based on its worldwide presence in the countries such as North America (U.S., Canada, and the Rest of North America), Europe (Germany, U.K., France, Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. In 2020, North America is expected to lead the medical device testing market in terms of market share. This is due to the presence of several key market players in the region, including testing laboratories and certification bodies. Additionally, stringent regulatory requirements and high demand for medical devices in the region are expected to drive the growth of the medical device testing market in North America.

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According to UnivDatos Market Insights (UMI)’, the key players with a considerable market share in the medical device testing market are SGS Société Générale de Surveillance SA, Intertek Group plc, Bureau Veritas S.A., Dekra SE, TÜV SÜD, Eurofins Scientific, British Standards Institution (BSI) Group, Element Materials Technology, UL LLC, and Charles River Laboratories.

“Global Medical Device Testing Market” provides comprehensive qualitative and quantitative insights on the industry potential, key factors impacting sales and purchase decisions, hotspots, and opportunities available for the market players. Moreover, the report also encompasses the key strategic imperatives for success for competitors along with strategic factorial indexing measuring competitors’ capabilities on different parameters. This will help companies in the formulation of go-to-market strategies and identifying the blue ocean for its offerings.      

Market Segmentation:

1.       By Service Type (Testing Services, Inspection Services, and Certification Services)

2.       By Testing Type (Physical Testing, Chemical/Biological Testing, Cybersecurity Testing, Microbiology & Sterility Testing, and Others)

3.       By Phase (Preclinical and Clinical)

4.       By Product (Active Implant Medical Device, Active Medical Device, Non-Active Medical Device, In-vitro Diagnostics Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Others

5.       By Sourcing Type (In-House and Outsourced)

6.       By Device Class (Class I, Class II, and Class III)

7.       By Region (North America, Europe, Asia-Pacific, Rest of the World)

8.       By Company (SGS Société Générale de Surveillance SA, Intertek Group plc, Bureau Veritas S.A., Dekra SE, TÜV SÜD, Eurofins Scientific, British Standards Institution (BSI) Group, Element Materials Technology, UL LLC, and Charles River Laboratories)

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Key questions answered in the study:

1.       What are the current and future trends in the global medical device testing industry?

2.       How the industry has been evolving in terms of service type, testing type, phase, product, sourcing type, and device class?

3.       How the competition has been shaping across the countries followed by their comparative factorial indexing?

4.       What are the key growth drivers and challenges for the global medical device testing industry?

5.       What is the customer orientation, purchase behavior, and expectations from the global suppliers across various region and countries?