Who will drive innovation in device and diagnostic development next year?
As we head into 2026, the bar for selecting medical device contract research organization partners is rising. Medical device and diagnostic companies no longer need a vendor that conducts trials: they need a strategic partner. Evolving regulation (MDR/IVDR), rapid technology shifts (software, AI/ML, connected devices), and post-market evidence expectations demand integrated support: regulatory strategy, clinical operations, human-factors, quality assurance, market access, and real-world data.
The strongest partnerships minimize friction through coordinated end-to-end support, ensuring your development strategy aligns across every phase. This article profiles ten CROs worth considering in 2026, each with distinct strengths in geography, specialization, and service breadth.
When evaluating CROs for your device or diagnostic project, you should look for:
Veranex is the industry's first Innovation CRO, headquartered in Raleigh, North Carolina and operating globally with hubs in Providence, Minneapolis, London, Paris, Switzerland, Sweden and Bangalore. Uniquely positioned as a device-first partner, Veranex delivers integrated, end-to-end support spanning product design and engineering, preclinical research and pathology, clinical investigation from early feasibility through pivotal trials, and comprehensive regulatory, quality and biocompatibility expertise, all underpinned by a commercialization team engaged from day one. This singular focus on medical devices and IVDs eliminates fragmentation across development phases, enabling smarter designs, de-risked trials, and seamless alignment of regulatory, quality, and market access strategy through a single, coordinated framework. Learn why Veranex is the industry’s first Innovation CRO.
Founded in 1967, NAMSA is headquartered in Northwood, Ohio and operates across North America, Europe and Asia. The firm provides deep expertise in preclinical testing (biocompatibility, microbiology, sterility), regulatory consulting, and laboratory infrastructure for device and IVD sponsors. NAMSA's technical capabilities support clients through preclinical and compliance phases, with established relationships across major international markets.
3. MCRA
MCRA operates from offices in Washington D.C., Hartford (Connecticut), New York and extends globally into Europe and Japan. The firm delivers regulatory strategy, clinical research operations (site selection and monitoring), and reimbursement consulting for medical device, diagnostic and biologic companies. MCRA brings strong expertise in clinical trial execution and market access strategy, serving device manufacturers across multiple geographies and therapeutic areas.
4. Avania
Based in Bilthoven, Netherlands with locations in the U.S. (Marlborough, Massachusetts), Canada (Toronto), Germany (Frankfurt) and Australia (Melbourne/Sydney), Avania provides strategic consulting, clinical operations, data analytics and market access support for devices, diagnostics and combination products. The company serves clients across multiple development and commercialization stages, with established regional expertise and operational capabilities in key geographies.
IQVIA is headquartered in Durham, North Carolina with operations in over 100 countries. Alongside dedicated pharmaceutical and clinical research segments, the firm serves device and diagnostic sponsors through its MedTech division. The firm offers clinical operations, regulatory and lifecycle consulting, real-world evidence analytics and market access support. IQVIA's global infrastructure and scale provide clients with extensive clinical trial capabilities and data analytics resources for device development and commercialization.
6. Medpace
U.S.-based with global trial operations, Medpace delivers comprehensive CRO services for devices and diagnostics including clinical trial execution, integrated laboratory and imaging operations, regulatory strategy and cross-geography trial management. The company brings specialized expertise in clinical data integration and regulatory consulting, supporting device manufacturers across multiple device types and therapeutic areas with established operational infrastructure worldwide.
7. Syneos Health
Operating globally from U.S. headquarters in Morrisville, North Carolina, Syneos Health provides clinical trial operations, hybrid and decentralized trial models, patient-engagement platforms and commercialization support for device and diagnostic firms across multiple regions. The organization brings innovation in trial design and execution, offering specialized infrastructure for remote monitoring and patient recruitment alongside go-to-market strategy services.
8. ICON plc
Founded in 1990, ICON plc is headquartered in Dublin, Ireland with operations in over 40 countries and a workforce of more than 40,000 employees. As an outsourced development and commercialization services provider to pharmaceutical, biotechnology and medical device companies, ICON serves device and diagnostic sponsors through clinical operations (from first-in-human through large post-market programs), regulatory and quality systems consulting (for devices, IVDs and combination products), global market access support and data/analytics infrastructure. ICON brings extensive global reach and scaled trial operations across multiple geographies and device types.
9. Qserve
Qserve CRO is headquartered in Arnhem (Netherlands) with offices across Europe, the U.S. and China, specializing in clinical trial design and execution (from feasibility through post-market clinical follow-up and registries), regulatory consulting and quality/audit services for device and IVD manufacturers. The firm supports clients across multiple development phases, with particular depth in trial operations, regulatory compliance and post-market surveillance strategy in European and key international markets.
10. ClinChoice
Headquartered in Horsham, Pennsylvania, USA, and operating globally with offices across the Americas, Europe and Asia-Pacific, ClinChoice offers full-service CRO support across pharmaceuticals, biotechnology, medical devices and diagnostics. For the device/diagnostic sector, services include clinical development (feasibility & site selection, monitoring, biometrics/data management), regulatory affairs, post-market real-world‐evidence work, project management, quality & compliance, and technology consulting.
Regulatory & Technology Complexity: Regulators (FDA, EU, APAC) are tightening scrutiny on human-factors, usability, software (SaMD), AI/ML integration, and data privacy. New biocompatibility standards are taking effect per ISO 10993-1:2025 and the U.S. FDA’s Quality Management System Regulation (QMSR) is set to take full effect in February 2026. Your CRO must have depth here—not just compliance knowledge, but proactive strategy to embed these considerations early.
Real-World Evidence is Now Essential: Post-market clinical follow-up and registries are no longer optional; they're table-stakes for reimbursement and competitive positioning. Select a partner with demonstrated capability in RWE design and execution, not just trial management.
Decentralized & Hybrid Models Demand Digital Infrastructure: Remote monitoring, electronic data capture, and connected devices require robust digital infrastructure and data governance. Ensure your CRO has proven systems in place—not aspirational plans.
Manufacturing & Quality Planning Must Be Integrated Early: Early integration of manufacturing design, quality systems, and regulatory documentation reduces delays and cost overruns. Look for a CRO that bridges clinical and manufacturing strategy, not one that hands off at trial completion.
Do they have experience with your specific device classification, especially including considerations for software, sensors, combination products, and diagnostics?
Can they support regulatory strategy in your target markets (e.g., FDA, EU Medical Device Regulation (MDR) / In Vitro Diagnostic Regulation (IVDR), APAC)?
Do they offer full-lifecycle services, or will you need to engage multiple vendors?
How strong are their digital/data systems (EDC, remote monitoring, connected devices, data governance)?
What is their documented track record (approval rates, timeline adherence, reference clients)?
How capable are they in usability/human-factors, real-world evidence/registries and market access strategy?
How flexible are they? Can they scale with you or provide functional services only as needed?
Selecting the right medical device CRO partner in 2026 requires balancing several key factors: device-specific expertise, regulatory depth, full-lifecycle capacity, and proven execution. The stakes are high: 75% of US MedTech startups fail before getting FDA approval, highlighting the critical importance of partnering with a medical device CRO that understands your specific challenges from the outset.
The best medical device CRO choice depends on your program's scope, geography, and timeline, and critically, on your organization's size and stage. Startups and emerging device companies require a medical device CRO with hands-on support through feasibility studies, regulatory pathway definition, and scaled clinical operations. Mid-size MedTech organizations need partners who can integrate clinical strategy with manufacturing planning and reimbursement support. Large strategic multinationals and established companies often benefit from a medical device CRO with global reach, decentralized trial infrastructure, proven commercialization, acquisition and innovation strategy work, and real-world evidence capabilities.
Look for a partner that minimizes hand-offs and complexity: one offering integrated support across design, manufacturing, regulatory, preclinical, clinical, quality, and commercialization. True device-specificity matters; a medical device CRO rooted in the device space will understand the unique regulatory pathways, manufacturing constraints, and market access considerations that differ from pharma development.
Your ideal partner should feel like an extension of your team, streamline activities and handoffs and provide the experience you need exactly when you need it accelerating your path to approval and launch.
Ready to navigate regulatory complexity, streamline clinical execution, and accelerate your path to launch?