Medical Device CRO Market to Reach USD 16.4 Billion by 2030

The Global Medical Device Contract Research Organization (CRO) Market is expanding rapidly as manufacturers increasingly outsource clinical research, regulatory submissions, validation testing, and post-market studies to specialized CRO partners. According to Exactitude Consultancy, the market is projected to grow from USD 9.25 billion in 2023 to USD 16.4 billion by 2030, reflecting a CAGR of 8.5% during 2024-2030.
With medical devices becoming more complex-AI-enabled systems, wearables, diagnostics, implantables, and Software as a Medical Device (SaMD)-CRO services have become central to accelerating approvals and ensuring global compliance.

Download Full PDF Sample Copy of Market Report @ https://exactitudeconsultancy.com/request-sample/73482

Key Takeaways
• Market Size 2023: USD 9.25 billion
• Market Size 2030: USD 16.4 billion
• CAGR (2024-2030): 8.5%
• Core Services: Clinical trials, regulatory affairs, product testing, biostatistics, data management, and post-market surveillance.
• Fastest Growing Area: Clinical research outsourcing for implantables, diagnostics, orthopedic, cardiovascular, and digital health devices.

Market Story
As global regulations tighten-especially under EU MDR/IVDR, FDA 21 CFR Part 820/814, PMDA, and NMPA-medical device companies are facing rising requirements for safety, clinical evidence, and post-market performance monitoring.
CROs help bridge technical, clinical, and regulatory gaps by offering specialized expertise across:
• Clinical trial design & execution
• Biocompatibility & preclinical testing
• Human Factors & Usability Engineering (HFUE)
• Risk management (ISO 14971)
• QMS (ISO 13485) consulting
• Clinical Evaluation Reports (CER) & PMCF studies
• Regulatory submissions & database management
Additionally, as medical technology becomes AI-driven and digital, CROs provide essential support for SaMD validation, cybersecurity testing, real-world evidence (RWE), and data analytics.

Market Segments
By Service Type
• Clinical Research Services
- Feasibility Studies
- Pilot & Pivotal Clinical Trials
- PMCF & Post-Market Studies
• Regulatory Affairs Services
- MDR/IVDR compliance
- FDA submissions (510(k), PMA)
- Global product registration
• Preclinical Testing
- Biocompatibility
- Toxicology
- Mechanical & Performance Testing
• Human Factors & Usability Studies
• Biostatistics & Data Management
• Laboratory Testing Services
• Reimbursement Consulting
Clinical research is the largest segment, followed closely by regulatory affairs.

By Device Category
• Class I Devices
• Class II Devices
• Class III Devices (Highest Complexity)
• In Vitro Diagnostics (IVDs)
• Wearables & Digital Health Devices
• Software as a Medical Device (SaMD)
Class III and SaMD require the most extensive CRO involvement.

By End-User
• Medical Device Manufacturers
• IVD Manufacturers
• Pharmaceutical-Device Combination Product Companies
• Digital Health Firms
• Academic Research Organizations
Manufacturers and digital health companies represent the highest demand.

Explore Full Report here: https://exactitudeconsultancy.com/reports/73482/medical-device-cro-market

Recent Industry Developments
• 2024 - ICON plc expanded AI-driven analytics for device clinical trials.
• 2024 - IQVIA launched global real-world evidence platforms for device surveillance.
• 2023 - Medpace extended medical device and diagnostics clinical research operations across Europe.
• 2023 - Syneos Health strengthened human factors and regulatory consulting for MDR compliance.
• 2023 - NAMSA introduced integrated preclinical-clinical-regulatory pathways for faster device approvals.

Expert Quote
"CROs are becoming strategic partners in navigating MDR, FDA, and global regulatory expectations. As device complexity grows, outsourcing clinical, regulatory, and technical activities ensures faster approvals and stronger clinical evidence."
- Irfan Tamboli, Business Development Executive, Exactitude Consultancy

Key Market Drivers
1. Increasing Complexity of Medical Devices
Implantables, robotics, AI-driven systems, and SaMD require high-level testing and clinical validation.
2. Stricter Global Regulations
EU MDR/IVDR and FDA guidance are driving demand for specialized regulatory and clinical expertise.
3. Rising Clinical Evidence Requirements
Manufacturers require RWE, PMCF, and long-term safety data to maintain compliance.
4. Growth of Digital Health & SaMD
Software validation, cybersecurity testing, and algorithm transparency are major new CRO services.
5. Outsourcing Trend Among Manufacturers
Cost reduction, faster timelines, and access to specialized talent drive outsourcing.

Forecast Outlook (2024-2030)
The next growth wave will be driven by:
• Expansion of AI/ML-based device categories
• MDR legacy device recertification
• Increasing number of start-up device manufacturers
• Growth in real-world evidence (RWE) adoption
• Integration of digital clinical trial platforms
By 2030, AI-enabled and decentralized clinical trials (DCTs) will be among the most disruptive CRO innovations.

Regional Insights
North America
Largest share due to advanced device ecosystem, strong CRO infrastructure, and high FDA compliance needs.
Europe
Significant growth driven by MDR/IVDR transition and expansion of regional CRO capabilities.
Asia-Pacific
Fastest-growing region (CAGR > 9%) due to expanding med-tech manufacturing in China, India, Singapore, and South Korea.
Latin America & Middle East
Growth driven by increasing regulatory modernization and rising local device development.

Conclusion
The Medical Device CRO Market is growing rapidly as device manufacturers face heightened regulatory pressure, complex technology requirements, and increasing demand for robust clinical evidence. CROs will remain vital partners for accelerating approvals, ensuring quality, and enabling global market expansion through 2030.

This report is also available in the following languages : Japanese (医療機器CRO市場), Korean (의료기기 CRO 시장), Chinese (医疗器械CRO市场), French (Marché des CRO de dispositifs médicaux), German (Markt für Auftragsforschungsinstitute für Medizinprodukte), and Italian (Mercato CRO dei dispositivi medici), etc.

Request for a sample of this research report at (Use Corporate Mail ID for Quick Response) @ https://exactitudeconsultancy.com/request-sample/73482

Related Reports

Polyphenylsulfone Market
https://exactitudeconsultancy.com/reports/75750/polyphenylsulfone-market

High Voltage Amplifier Market
https://exactitudeconsultancy.com/reports/75826/high-voltage-amplifier-market

Acute Radiation Syndrome Market
https://exactitudeconsultancy.com/reports/76062/acute-radiation-syndrome-market

Electroless Plating Market
https://exactitudeconsultancy.com/reports/76137/electroless-plating-market

About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
https://bulletin.exactitudeconsultancy.com/

https://www.thehealthanalytics.com/

https://www.analytica.global/

https://www.marketintelligencedata.com/

https://www.marketinsightsreports.com/

https://exactitudeconsultancy.com/

Connect Us:
Irfan Tamboli
PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com

This release was published on openPR.