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Inside the EudraLex Annex 22: What’s New for AI in Pharma Manufacturing and Why These Revisions Matter
The adoption of AI in the pharmaceutical industry is accelerating, but at a...
Medical Devices
Are you looking for quality, regulatory or clinical support for your medical device? QbD Group can support you at any stage in the lifecycle of your medical device, from idea to patient.
We are experts when it comes to ISO13485, clinical evaluation/investigation, MDR, design and development, technical files, auditing, qualification, validation, risk management, software, and more.
Regulatory expertise you can trust
With in-depth knowledge of ISO 13485, MDR, and risk management, we help you navigate complex regulations to safely and effectively bring your device to market.
Comprehensive quality and clinical solutions
From establishing quality management systems to conducting clinical evaluations and investigations, QbD Group ensures your medical device meets the highest standards of safety and performance.
Post-market monitoring and maintenance
We support ongoing compliance by managing post-market monitoring and processes to maintain the safety and effectiveness of your medical device throughout its lifecycle.
Offering comprehensive Medical Device services
We provide end-to-end support across the entire MD lifecycle. Our services include:
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Authorized & legal representation
Navigating regulatory approvals in the EU? We act as your trusted legal representative, ensuring compliance with stringent European standards.
- Strategic regulatory guidance
- Submission planning & execution
- Ethics committee & competent authority submissions
- Study modifications & amendments
Learn more
Digital solutions
We offer cutting-edge software solutions to streamline regulatory compliance and quality management.
- Scilife (Smart QMS): Digital QMS for inspection readiness, risk mitigation, and compliance tracking.
- IFUcare: A full-service eIFU solution for digital technical documentation distribution.
Learn more
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Outsourcing solutions
Need extra expertise for your medical device projects? We provide flexible outsourcing solutions to support your team with:
- Regulatory Affairs & Quality Assurance Specialists:
- Clinical Research & Performance Evaluation Experts
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Post Market Surveillance (PMS) &
Post-Market Clinical Follow-up (PMCF) -
Project Management & Medical Writing Support
Get in touch
Meet our experts
Bringing a medical device to market demands specialized expertise in regulatory strategy, clinical evaluation, quality management, and compliance with evolving standards. At QbD Group, our experts blend in-depth industry knowledge with practical experience to guide you seamlessly through every phase of development, approval, and post-market surveillance.
Get to know some of our key team members who are dedicated to supporting your medical device journey.
Kristof Vanschoonbeek
Consultant Medical Affairs Coordinator - Clinical Team Manager
20+ years of experience in clinical research including 3 years in the MD field.
- Dual Leadership Roles at QbD Clinical
- Expertise in PMCF Survey Management
- Team Leadership and Development
- Extensive Background in Clinical Research and Academia
Julie Hendrickx
MD CRO Project Management Lead
20+ years clinical project delivery experience.
- International experience in Pharma and MD field
- 8+ years as Clinical Project Manager
- Project Management from study start-up to close-out
Petra De Geest
Medical Affairs Manager – Medical writing & Safety expert
12 years experience in MD field.
- MD clinical evidence and medical writing (Class I to Class III, including MDSW and AI-driven MDSW)
- Safety Management in MD clinical investigations
- Strategic leadership & consultancy
Sarah Andries
Clinical Regulatory Manager
12 years of experience in MD field.
- 10 years in Clinical Regulatory
- Regulatory Authority & Ethics committee submissions
- MDR & National legislations and requirements (EU)
- EU Legal Representative
How we can help you
QbD Group offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.
Get in touch
Partner with QbD Group to ensure your medical device meets the highest standards of quality and compliance. Fill out the form and our experts will help you navigate the development process with ease and efficiency.
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