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Medical Writing for Medical Devices - Clinical - QbD Group

Experts in Medical Device Clinical Trials

QbD Clinical is a European expert specializing in clinical trials for medical devices. We partner with companies worldwide, ensuring they meet the highest quality and safety standards, from concept to patient. We bring passion to everything we do, whether it’s a brief consultation or a full-service clinical trial.

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How can we help?

We have in-depth expertise in the challenges associated with medical devices, with a focus on cardiology, vascular, neurology, and orthopedics. Unlike CROs that primarily work with pharmaceuticals, we specialize exclusively in medical device clinical trials, offering expert support tailored to your needs.

Cardiology

  • Heart failure
  • Acute coronary syndromes
  • Atrial fibrillation
  • Coronary artery disease
  • Hypertension
  • Others

Vascular

  • Peripheral arterial disease
  • Aortic aneurysms
  • Carotid artery disease
  • Venous thromboembolism
  • Pulmonary hypertension
  • Others

Neurology

  • Alzheimer's disease
  • Parkinson's disease
  • Multiple sclerosis
  • Epilepsy
  • Stroke
  • Others

Orthopedic

  • Osteoarthritis
  • Rheumatoid arthritis
  • Spinal disorders
  • Fracture repair
  • Others

 

Medical Writing for Medical Devices - Clinical - QbD Group

Why QbD Group?

With over 10 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.

  • +52 therapeutic indications
  • +250 clients worldwide
  • +45 countries covered
  • +650 projects delivered
  • +2400 clinical sites
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Always glad to share our expertise

QbD Clincial offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.
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Quality Assurance

  • Implementation of FDA, EMA, FAHMP, and ISO standards (ISO13485, ISO14971, etc.)

  • Internal and external audits by certified lead auditors.

  • Lifecycle management for Medical Device Software and digital health solutions.
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Clinical Services

  • Strategy and protocol development for clinical evidence generation.

  • Site selection, monitoring, and regulatory support.

  • Comprehensive medical writing, incl. scientific validity reports and post-market clinical follow-up documentation.
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Regulatory Affairs

  • CE Marking, FDA clearance, and market entry strategies.
  • Technical documentation and submission packages for MDR and global markets.

  • PRRC services, in-country representation, legal representation, and post-market regulatory support.
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Your journey from idea to patient

See where QbD fits into every stage of your device development — from ideation to post-market surveillance.
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Client cases: real-world results across therapeutic areas

Explore some of our recent studies and projects, ranging from SaMD and heart failure to stroke and osteoarthritis. Our support spans across continents and trial phases.
Vascular SaMD

Vascular | SaMD

  • Supported a 5-year post-market registry for coronary artery disease SaMD across 4 sites in the Middle East, Europe, and the US.
  • Delivered full project oversight, site management, and local resource support for 394 subjects.
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Cardio Heart Failure

Cardio | Heart Failure

  • Managed a First-in-Human follow-up study for in-heart microcomputer technology targeting ischemic heart disease.
  • Spanning 12 sites in Europe and the Middle East with 30 enrolled subjects, we provided regulatory submissions, monitoring, and MDR consulting.
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Neuro Stroke

Neuro | Stroke

  • Led a pivotal interventional study across the EU and US for stroke-related aspiration catheters.
  • Forecasted for 277 subjects, our full CRO services included submissions, biostatistics, and data management.

 

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Ortho Osteoarthritis

Ortho | Osteoarthritis

  • Oversaw a First-in-Human startup study for intra-articular hydrogel injections treating knee osteoarthritis.
  • Conducted at up to 6 sites in Belgium, with full medical writing, biostatistics, and safety monitoring support for 99 forecasted subjects.

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Get in touch

Ready to accelerate your medical device trial? Let’s talk.

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Resources

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Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.
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Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!
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Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.
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Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.
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Blog

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR

We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior...
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Blog

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the...
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Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

It shouldn’t be a surprise that today, “Near-Patient Testing (NPT)” and...
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Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

In the European regulatory landscape, conducting performance studies for in...
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