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QPPV / Local Representative
Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide.
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.
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
-
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.
Industry challenges
Medical devices are regulated by laws that govern the safety and performance of devices across their lifetime, from pre- to post-market. A risk-based classification system determines the requirements for medical devices.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Manufacturers must ensure to only place medical devices in the market that comply with the legislative requirements.
This requires documentation of the design, development, and manufacturing process of the device including sufficient clinical evidence that shows the device is safe and performs as intended.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
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Industry challenges
Medical devices are regulated by laws that govern the safety and performance of devices across their lifetime, from pre- to post-market. A risk-based classification system determines the requirements for medical devices.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Medical devices with higher risks for the users require Notified Bodies to perform assessments on the safety and performance of the device. In this way, they ensure the continued safety and performance of medical devices, pre-, and post-market.
Manufacturers must ensure to only place medical devices in the market that comply with the legislative requirements.
This requires documentation of the design, development, and manufacturing process of the device including sufficient clinical evidence that shows the device is safe and performs as intended.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
By establishing a quality management system and documented procedures for manufacturing and post-market monitoring activities, the quality of the product is maintained leading to continued safety and performance of the medical device during its lifecycle.
Our offerings for Medical Devices in
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Why QbD Group?
YOUR MEDICAL DEVICES INDUSTRY EXPERT
Within QbD Group, we have the knowledge and expertise to support manufacturers, distributors, and importers of medical devices in complying with the legislative requirements during the complete lifecycle of a medical device.
Our clinical, regulatory, and quality experts know what needs to be done to be able to comply with the legislative requirements by which a medical device can be safely placed on the market.
Furthermore, we keep supporting businesses by managing the processes that ensure the medical device continues to be safe and effective, before and after placing it on the market.
10+ years of experience
Full lifecycle support
Global presence
Best managed company
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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