Notified Body Submissions
Your path to CE marking
Navigating the submission process to a notified body is an essential step in obtaining CE marking for medical devices and in-vitro diagnostics. We offer comprehensive support tailored to your requirements.
How can we support you?
Navigating the submission process to a notified body (NB) is an essential step in obtaining CE marking for medical devices and in-vitro diagnostics.
At QbD Group, we recognize the complexity and challenges involved in this process. That's why we offer comprehensive support tailored to your specific requirements, ensuring a smooth path to regulatory compliance.
Why partner with QbD Group?
Our deep experience with Notified Body submissions ensures a smooth path to CE marking.
Expert guidance
Our team has in-depth knowledge of regulatory requirements and notified body expectations.
Efficient advocacy
We act as your liaison during the assessment process, addressing inquiries, resolving issues, and advocating on your behalf.
First time right principle
By ensuring accuracy and thoroughness in every step, we minimize delays and increase the likelihood of successful submissions.
Strong NB relationships
Our rapport with notified bodies facilitates faster interactions and smoother assessments, saving you valuable time.
Our support areas
We offer comprehensive support for every aspect of the Notified Body submission process:
Customized roadmap to CE marking
We create a step-by-step plan to achieve CE marking, aligning with your device classification, intended use, and market goals.
Transition support
Whether transitioning from IVDD to IVDR or AIMDD/MDD to MDR, we guide you through the regulatory updates, ensuring compliance with the latest requirements.
Gap assessments
Our experts conduct detailed reviews of your existing technical documentation to identify and address gaps, ensuring completeness and accuracy before submission.
Technical documentation preparation
We handle the composition and writing of your technical documentation, meticulously ensuring it meets notified body expectations and regulatory standards.
Selection and submission to Notified Body
Why QbD Group
Your trusted partner
Our deep experience with Notified Body submissions ensures a smooth path to CE marking.
Proven track record of successful NB submissions across all device classes.
Direct experience with major European Notified Bodies.
Expertise in both MDR and IVDR submission requirements.
End-to-end support from gap assessment through certification.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.