North America Medical Device Testing Market is expected to reach the value of USD 4,904.16 million by 2030

The rising need for the verification and validation of medical devices globally has enhanced the growth of the market. Some of the major market players are highly focusing on various service launches and service approvals during this crucial period. In addition, the increasing demand for in-vitro tests is also contributing to the rising demand for medical device testing. The North America medical device testing market is growing in the forecast year due to a rise in market players and the availability of advanced services.

However, the barriers to the local development of medical devices and the high cost of medical devices might hamper the growth of the North America medical device testing market in the forecast period.

Data Bridge Market Research analyzes that the North America medical device testing market is expected to reach the value of USD 4,904.16 million by 2030, at a CAGR of 12.0% during the forecast period.

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Medical device testing is the process of demonstrating that the device is reliably and safely performed in use. In new product development, extensive design validation testing is applied. This includes performance testing, toxicity, chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This usually includes dimensional checks, some functional tests, and packaging verification. Various types of medical testing services are available there in the market, such as inspection services, certification services, and others.

North America Medical Device Testing Market Dynamics
This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:

Drivers

Rising Need for Verification Validation of Medical Devices
Medical device testing is the process of demonstrating that the device will reliably and safely perform diagnosis and treatment. The demand for medical devices is constantly rising as there is a high prevalence of various diseases seen among various regions across the globe.

The methods of verification and validation are widespread and extensively being used in the healthcare industry. In general, verification is the developmental phase of a product if it complies with the specified requirements, whereas validation checks if the intended use has been met and, thus, usability specifics are fulfilled. The most common types of verification and validation for medical devices are design, process, and software verification and validation.

Medical devices are also becoming smaller and more complex in design using advanced, engineered plastics. This makes the process of validation and verification (V&V) all the more important. The results in better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower production costs. Additionally, increasing standards and regulations about medical device validation and verification services are anticipated to drive the growth of the medical device testing market.

Increasing Demand for In-Vitro Tests
In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.

In-vitro tests are used in various disease detections, such as HIV infections, malaria, and hepatitis, among others. The prevalence of such diseases is rapidly increasing across the globe, which leads to the increasing demand for in-vitro tests and various medical devices. As medical devices have become widely available for various diseases due to the rapid manufacturing of medical testing companies, it is a major factor driving the growth of the market.

Recent Developments

In April 2021, TÜV SÜD announced that it had presented itself at Medtec LIVE to exhibit its ability to be a one-stop shop for medical device testing. The company's services cover testing in electrical and functional safety, cyber security and software, EMC, and biocompatibility. The experts from TÜV SÜD featured in the program of the online trade show and congress with various talks, a live hack, and an elevator pitch.
In June 2020, Intertek announced the expansion of its personal protective equipment services to include precertification testing of N95 respirators to requirements set by the National Institute for Occupational Safety and Health (NIOSH). The new services are the result of the successful accreditation to NIOSH Standard Test Protocols, in accordance with ISO 17025. With these new services, Intertek expands upon its solutions and resources to support customers and the global community during the COVID-19 pandemic.

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North America medical device testing market Scope
North America medical device testing market is segmented into service type, testing type, phase, sourcing type, device class, and product. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Service Type

Testing Services
Inspection Services
Certification Services
On the basis of service type, the North America medical device testing market is segmented into testing services, inspection services, and certification services.

Testing Type

Physical Testing
Chemical/Biological Testing
Cybersecurity Testing
Microbiology And Sterility Testing
Others
On the basis of testing type, the North America medical device testing market is segmented into physical testing, chemical/biological testing, cybersecurity testing, microbiology and sterility testing, and others.

Phase

Preclinical
Clinical
On the basis of phase, the North America medical device testing market is segmented into preclinical and clinical.

Sourcing Type

In-House
Outsourced
On the basis of sourcing type, the North America medical device testing market is segmented into in-house and outsourced

Device Class

Class I
Class II
Class III
On the basis of device class, the North America medical device testing market is segmented into class I, class II, and class III.

Product

Active Implant Medical Device
Active Medical Device
Non-Active Medical Device
In Vitro Diagnostic Medical Device
Ophthalmic Medical Device
Orthopedic and Dental Medical Device
Vascular Medical Device
Others

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