Clinical Solutions for Medical Devices, In Vitro Diagnostics and Companion Diagnostic
End-to-end clinical support that helps MedTech innovators move from early strategy to regulatory-ready execution — with confidence, speed and compliance.
From gap assessment to full CRO delivery
We support medical device, IVD and CDx developers with integrated clinical strategy, study design and trial execution.
Regulatory-aligned by design
Our experts ensure clinical evidence meets MDR, IVDR and performance evaluation requirements, without late-stage surprises.
One partner across the lifecycle
As a full-service CRO, we guide you from early evidence planning through clinical operations and post-market activities.
Clinical Excellence in MD, IVDs and CDx
End-to-end clinical delivery
Regulatory confidence by design
Regulatory confidence by design
Focused expertise for MedTech innovators
Focused expertise for MedTech innovators
Our Clinical CRO Services
Medical Device CRO
Clinical studies and evidence generation for medical devices across the full lifecycle.
From early feasibility and global pivotal studies to post-market clinical follow-up, we support medical device manufacturers with clinical strategy, study execution and MDR-aligned evidence.
Why QbD Group?
With over 20 years of experience, QbD Clinical delivers flexible, tailored clinical solutions to help bring medical devices to market efficiently while ensuring compliance with MDR and ISO 14155.
Medtech expertise
We deliver clinical development and validation for medical devices, IVDs and CDx, supported by dedicated MedTech and CDx teams across the full clinical lifecycle.
Trusted partner
We support MedTech companies with regulatory expertise across MDR, FDA, IVDR, ISO 14155, ICH-GCP, and our close collaboration with Notified Bodies, enabling trust, transparency, and faster outcomes.
Quality at every step
Quality is ensured at every stage, from study design to trial execution. We reduce risk through rigorous processes while maintaining operational efficiency.
Right-sized solutions on budget
Our flexible approach ensures cost-effective clinical solutions that scale with your program, without compromising on quality.