The global medical device validation and verification market size is expected to reach USD 1.71 billion by 2030, expanding at a CAGR of 8.8% from 2025 to 2030, according to a new report by Grand View Research, Inc.

Increase in demand for advanced and quality medical products and rising complexity with respect to product designing and engineering are anticipated to boost market growth. Rapid innovations in healthcare have increased the need for companies to incorporate new technologies and software applications in their products to meet the demand for validation and verification. Increase in product complexity, availability of newer types of material, and high risk of product failures are some of the key factors increasing the need for validation and verification services.

North America dominated the global medical device validation and verification market, accounting for 44.88% share of the overall revenue in 2019. Rapid growth in manufacturing of medical devices to meet high demand for efficient healthcare services, including validation and verification, is one of the major factors contributing to the regional market growth. In addition, stringent regulatory environment in U.S. is fueling market growth in the region.

Asia Pacific is anticipated to expand at a CAGR of 12.1% during the forecast period. This can be attributed to increased opportunities for players, especially in Japan, China, and India, improved regulatory framework, and increase in the number of medical devices companies.

Medical Device Validation Verification Market Report Highlights

• The oncology segment dominated the market, with a revenue share of 26.5% in 2024, driven by the rising incidence of cancer globally, demanding advanced medical devices for diagnosis, treatment, and monitoring.
• The diagnostics segment dominated the market with the largest revenue share of 44.0% in 2024, driven by increasing demand for early disease detection and a shift towards preventive healthcare, emphasizing early diagnosis for better treatment outcomes and lower costs.
• The therapeutic segment is projected to grow at a CAGR of 9.0% over the forecast period. It is fueled by the rising prevalence of chronic diseases like diabetes and cardiovascular conditions, demanding validated devices such as drug delivery systems and infusion pumps for effective management.
• North America medical device validation verification market dominated the global market with a revenue share of 45.2% in 2024.

Medical Device Validation Verification Market Segmentation

Grand View Research has segmented the global medical device validation verification market on the basis of therapeutic area, application, implants, technology, and region:

Medical Device Validation Verification  Therapeutic Area Outlook (Revenue, USD Billion, 2018 - 2030)

• Cardiovascular
• Dermatology
• Orthopedics
• Nephrology
• Respiratory
• Neurology
• Oncology
• ENT
• Others

Medical Device Validation Verification Application Outlook (Revenue, USD Billion, 2018 - 2030)

• Diagnostics
• Therapeutic
• Implants

Medical Device Validation Verification Implants Outlook (Revenue, USD Billion, 2018 - 2030)

• Active Implantable Medical Device
• Medical Implants

Medical Device Validation Verification Technology Outlook (Revenue, USD Billion, 2018 - 2030)

• Mechanical Testing
• Biological
• EMI/EMC
• Electrical Safety Testing

Medical Device Validation Verification Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America
  • US    
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Order a free sample PDF of the Medical Device Validation and Verification Market Intelligence Study, published by Grand View Research.