Medical Device Validation and Verification Market Worth by 2031

Offers a comprehensive overview of the market's current state and future growth trajectory. It identifies key drivers, challenges, and opportunities, providing valuable insights for various business stakeholders. According to the report's forecast, the sector is set to witness a steady expansion in market size, market share, and innovation over the next six years.

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Key Growth Drivers
The press release details five major factors propelling the market forward:
1. Stringent Regulatory Requirements: Governments and regulatory bodies, such as the FDA and EMA, are mandating rigorous validation and verification processes. These regulations are designed to ensure the safety and effectiveness of medical devices. This regulatory push compels manufacturers to invest in compliance solutions, which, in turn, drives market growth across all classes of devices.
2. Increasing Complexity of Medical Devices: Modern medical devices are becoming increasingly complex. They often integrate sophisticated software, advanced connectivity, and new technologies. This complexity necessitates thorough validation and verification to ensure functionality, performance, and cybersecurity. The need for specialized testing services and tools to manage this complexity is significantly boosting market demand.
3. Rising Focus on Patient Safety: There is a growing emphasis on reducing medical errors and improving patient outcomes within the healthcare industry. To achieve this, healthcare providers and manufacturers are prioritizing robust validation and verification processes. Ensuring the reliability and accuracy of devices is critical to preventing patient harm, which is a key factor fueling demand in this essential segment of device development.
4. Technological Advancements in Testing Solutions: Innovations in the field of medical device testing are making the validation and verification process more efficient and reliable. Advances in automated testing, simulation software, and digital validation tools are reducing both the time and cost involved. This encourages more manufacturers to adopt these advanced technologies, thereby expanding the market.
5. Growth in the Medical Device Industry: The global medical device industry is expanding rapidly, driven by the increasing prevalence of chronic diseases, an aging population, and rising healthcare spending. As more devices are introduced to the market to meet these needs, the demand for comprehensive validation and verification processes grows proportionally, directly contributing to the market's expansion.

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Recent News and Developments
The press release also highlights recent strategic moves by leading companies that are shaping the future of the market:
• On July 15, 2025, Intertek, a global quality assurance provider, announced a significant expansion of its Medical Notified Body's scope under the EU's Medical Device Regulation (MDR). This expansion, which includes 16 new MDR codes, broadens Intertek's capabilities to assess and certify a wider range of medical device technologies and manufacturers.
• On March 26, 2025, Eurofins Medical Device Services opened a new site in San Jose, California, specializing in Ethylene Oxide (EO) Sterilization. The site offers high-quality, fast-turnaround contract sterilization and validation services for the medical device industry.
• In June 2024, Element Materials Technology launched Element RegNav, its first artificial intelligence (AI)-powered regulatory intelligence platform for medical devices. Initially designed to support FDA regulatory pathways, RegNav aims to help bring medical innovations to market more safely and reliably.
• In April 2024, Charles River Laboratories International, Inc. announced the launch of its Alternative Methods Advancement Project (AMAP). This initiative is dedicated to developing alternatives to reduce animal testing and represents a total investment of $500 million over nine years.

Key Players operating in the Medical Device Validation and Verification Market
• SGS SA
• QuEST Global Services Pte. Ltd
• Intertek
• Element Materials Technology
• North American Science Associates, Inc
• Eurofins Scientific SE
• Charles River
• Sterling Medical Devices
• Pacific Biolabs

Future Outlook and Market Analysis
According to the report, the Medical Device Validation and Verification Market is expected to grow steadily. This growth will be sustained by several factors, including the increasing complexity of devices, stricter regulatory requirements, the integration of new technologies like AI, growing cybersecurity demands, and the adoption of automation to streamline testing and compliance processes.

The Insight Partners' analysis suggests that the market is experiencing rapid growth, driven by rising end-user demand influenced by evolving consumer preferences, technological innovations, and a greater awareness of product benefits. The report indicates that companies are actively expanding, innovating, and leveraging these trends to maintain their momentum.

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This release was published on openPR.