Qualification & Validation
Qualification & Validation
Quality Assurance
Quality Assurance
Regulatory Affairs
Regulatory Affairs
Clinical
Clinical
Lab Services
Lab Services
Vigilance
Vigilance
Software Solutions & Services
Software Solutions & Services
Tox green
Toxicology
Pharma (2)
Pharma & Biotech
Medical Devices (2)
Medical devices
IVD (2)
In vitro diagnostics
Search QbD Group
  • There are no suggestions because the search field is empty.
Medical Writing for Medical Devices - Clinical - QbD Group

Experts in Medical Device Clinical Trials

QbD Clinical is a European expert Clinical Research Organization (CRO), 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.

Read more

 

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
  • +50 countries covered
  • +92 clinical experts worldwide
  • +200 clinical trials
  • +650 projects delivered
  • +2400 clinical sites

 

Contact us

 

Always glad to share our expertise

QbD Clincial offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.
Explore our services
QualityAssurance_Get in touch

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.

Learn more
Circles_Get in touch_clinical-1

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.
Learn more
RA_Get in touch

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.

Learn more

Your journey from idea to patient

We support you in every stage of your device development — from ideation to post-market surveillance.
MD Life Cycle -1-1

Recent 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.
Get in touch
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.
Get in touch
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.

 

Get in touch
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.

Get in touch

CRO services

At QbD Group, our Clinical Operations (ClinOps) team provides comprehensive support across all phases of clinical research, from early development to post-market follow-up.
 
We handle the entire clinical trial process, including project management, site selection and qualification, site training and oversight, risk-based monitoring both on-site and remotely, and logistical coordination.

In addition to operational support, our experts offer services in medical and technical writing, quality and safety management, clinical regulatory affairs, and data management.

Feasibility

Regulatory submissions

Medical writing

Data management

Monitoring

Site management

Project management

Safety management (CEC, DSMB)

Supply management

Core lab management

Quality

Legal representative

contact-mail

Get in touch

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

Circles_Get in touch_clinical

Resources

preview_image
Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.
Read more
preview_image
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.
Read more
preview_image
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!
Read more
preview_image
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.
Read more
preview_image
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.
Read more
preview_image
Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.
Read more
preview_image
Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.
Read more
preview_image
Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.
Read more
preview_image
Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.
Read more
preview_image
Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.
Read more
preview_image
Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.
Read more
preview_image
Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
Read more
preview_image
Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
Read more
Discover all