Clinical Services  Our Services - QbD Group

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

At QbD Group, we deliver clinical development and validation for MD, IVDs and CDx, combining high-quality gap assessments, expert medical writing and full-service CRO execution.

End-to-end clinical delivery

End-to-end clinical delivery

From early feasibility through post-market studies, our specialized clinical teams ensure the right expertise is applied at every stage of your clinical strategy.

Regulatory confidence by design

Regulatory confidence by design

We support MDR, IVDR and CDx requirements from the start — minimizing rework during Clinical Trial Application preparation, notified body interactions and inspections.

Focused expertise for MedTech innovators

Focused expertise for MedTech innovators

With deep knowledge of specific technologies and regulatory pathways, QbD Group is a trusted partner for small and mid-sized MedTech companies seeking clear guidance and reliable execution.

 

Our Clinical CRO Services

Clinical CRO support tailored to medical devices, IVDs and companion diagnostics.
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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.

Industry - In Vitro Diagnostics - QbD Group

In Vitro Diagnostics CRO

Clinical performance studies supporting IVDR compliance.

We help IVD developers design and execute performance studies, ensuring clinical evidence meets IVDR requirements and notified body expectations.

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Companion Diagnostics (CDx)

Integrated clinical and regulatory support for CDx development.

We support CDx programs in close alignment with drug development, ensuring clinical evidence, regulatory strategy and timelines remain synchronized.

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.

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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.

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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.

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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.

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Right-sized solutions on budget

Our flexible approach ensures cost-effective clinical solutions that scale with your program, without compromising on quality.

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Plan your clinical pathway

Whether you’re navigating clinical trials or ensuring regulatory compliance, our experts are here to guide you every step of the way. Let’s work together to bring your MD or IVD or CDx to market successfully.
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