Qserve CRO: Your Partner for Medical Device and IVD studies

At Qserve CRO, we embrace the practical approach. As a 100% medical device and IVD–dedicated Contract Research Organization (CRO), our mission is clear: supporting manufacturers in bringing safe, effective, and innovative medical devices and IVD to patients, while navigating the complex regulatory landscape with expertise and efficiency. 
 
We are proud to introduce the exceptional team driving this mission, made up of experienced clinical experts, strategists, and problem-solvers who are dedicated to advancing high-risk medical device research and ensuring global compliance. 

Who We Are 

Qserve CRO was founded in 2018 as part of the Qserve Group, which has supported the medical device industry since 1998 through regulatory, quality, and clinical expertise. Today, we operate on a global scale, with our headquarters in Arnhem, the Netherlands, and a strong presence throughout Europe, the United States, and China. 
 
Our team brings together deep regulatory knowledge and practical clinical execution. With more than 70 professionals, including Clinical Project Managers, Clinical Research Associates, Data Managers, Statisticians, Medical Writers, and Regulatory Experts, we deliver high-quality results across full-service trials as well as focused, specialized support. 
 
Our flexible global network of CRAs, operating in their respective countries and languages, ensures local compliance and efficient site management, giving clients the advantage of both global reach and local specific insights. 

Why Qserve CRO? 

Qserve CRO has the unique ability to merge clinical excellence with regulatory intelligence, ensuring every activity aligns with applicable standards and delivers meaningful outcomes for both patients and sponsors. 

• Focused on Medical Devices and IVD: 100% dedicated to medical devices and IVD — from high-risk implants to cutting-edge diagnostics and digital health solutions. 
• Regulatory-Driven Approach: We know the MDR, ISO 14155, GCP, GDPR, and other frameworks by heart, and we even advise clients not to proceed with a study if it doesn’t make regulatory or practical sense. 
• Global Yet Local: Our worldwide network combines international oversight with local expertise, ensuring seamless execution and compliance. 
• Tailored Support: Full-service trials, partial support, hybrid models — we adjust to meet your needs, budgets, and timelines. 

Our Expertise 

We specialize in high-risk medical device research, with proven experience in conducting pre-CE and post-CE clinical investigations, PMCF studies, registries, and surveys, all fully aligned with regulatory requirements. 
 
Our expertise serves many therapeutic areas, including: 

• Cardiovascular Innovation: Studies of stents, pacemakers, and other life-saving devices. 
• Neurological Breakthroughs: Research in neuromodulation, Parkinson’s disease, and chronic pain. 
• Orthopedic Excellence: Improving mobility and reducing pain through implants and prosthetics. 
• Respiratory Care Leadership: Validating ventilators, oxygen therapy, and sleep apnea treatments. 
• Ophthalmic Precision: Supporting vision restoration through intraocular lenses and retinal implants. 
• Wound Care & Dermatology: Advancing healing and patient satisfaction with innovative therapies. 
• Emerging Frontiers: Pioneering research in regenerative medicine, digital health, and personalized medicine. 
• Companion Diagnostics (CDx): CDx are assays that are required to be used before a specific therapy can be initiated. They are often co-developed together with a therapeutic treatment during its clinical development journey. Extensive testing in clinical trials is required, often in multiple sites across the globe. 

The People Behind the Projects 

Our multidisciplinary team offers deep expertise combined with a personal approach in every engagement. With backgrounds ranging from clinical strategy and project management to monitoring and regulatory auditing, our consultants are more than just specialists, they are trusted advisors. 
 
Some highlights of their competencies include: 

• Clinical strategy development and regulatory submission expertise in EU, US, and global markets. 
• Comprehensive study documentation, submissions, and interactions with Ethics Committees and Competent Authorities. 
• On-site monitoring, site qualification, audits, and close-out visits. 
• PMCF survey planning, execution, and reporting aligned with MDR requirements. 
• Cross-functional team leadership, vendor selection & management, and quality audits. 
• Deep therapeutic knowledge in cardiology, neurology, orthopedics, and more. 
• Proficiency in multiple languages and cultures to bridge communication gaps seamlessly. 

We also work with long-standing subcontractors, test labs, and partners, giving clients access to the most renowned facilities and services for animal studies, biocompatibility testing, and companion diagnostics. 

More Than Just a CRO 

At Qserve CRO, we do more than conduct studies, we support and guide you throughout the entire clinical journey: 

• Clinical Writing: Clear, regulatory-compliant clinical evidence tailored to your audience. 
• Global Registration: Navigating diverse regulatory landscapes and expanding your market reach. 
• Test Lab & Animal Study Support: Providing access to trusted, compliant facilities for specialized testing. 
• Companion Diagnostics & Biocompatibility: Ensuring your device integrates seamlessly with clinical workflows and meets safety standards. 

We combine the thoroughness of a consultancy with the operational agility of a CRO, helping you avoid unnecessary complexity, save time, and optimize your return on investment. 

Let’s Bring Your Innovation to Life 

Whether you are planning a full clinical trial, need support with monitoring, or are looking for regulatory guidance, Qserve CRO is ready to partner with you. From concept to market, we provide practical, compliant, and impactful solutions at every stage of your journey. 

Contact us today at info@qservecro.com.