Notified Body Submission - Regulatory Affairs - QbD Group

Notified Body Submissions

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.

How can we support you?

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
Leveraging our established relationships with several notified bodies, we help you select the right NB for your product and manage the submission process from start to finish.

Notified body submission - Regulatory Affairs - QbD Group (1)

Why partner with QbD Group?

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.