Liaison with Notified Bodies
Strategic management of Notified Body interactions
Engaging with a Notified Body is a critical milestone in the conformity assessment process. QbD Group acts as your trusted intermediary, ensuring all communications are clear, complete, and aligned with your regulatory strategy.
What is liaison with Notified Bodies?
Engaging with a Notified Body is a critical milestone in the conformity assessment process for medical devices and in vitro diagnostics. The quality and timing of your interactions with the Notified Body can significantly influence your path to CE marking.
Many manufacturers underestimate the complexity of Notified Body interactions. From initial contact and application submission to responding to review queries and managing audit follow-ups, every step requires regulatory precision and strategic communication.
QbD Group acts as your trusted intermediary, ensuring all communications with Notified Bodies are clear, complete, and aligned with your regulatory strategy.
How we support you
Our team brings extensive experience in managing Notified Body relationships, ensuring smooth and efficient interactions at every stage.
Strategic NB selection
We help you identify and select the most suitable Notified Body for your device classification and intended markets.
Application preparation
We prepare complete, audit-ready application packages that meet Notified Body expectations.
Timeline management
We proactively manage timelines and follow up on review milestones to prevent delays.
Audit readiness
We conduct gap assessments and mock audits to ensure your organization is fully prepared.
Communication coordination
We serve as the central point of contact, coordinating all exchanges between your team and the Notified Body.
Key areas of support
Our Notified Body liaison services cover the full spectrum of interactions:
Initial engagement
We help you select the right Notified Body and prepare your initial application package.
Query management
We coordinate responses to Notified Body questions, ensuring timely and technically sound replies.
Audit preparation
We prepare your team and documentation for Notified Body audits, including mock audits.
Ongoing liaison
We maintain continuous communication with your Notified Body throughout the product lifecycle.
Why QbD Group
Your trusted partner
QbD Group has a proven track record of successful Notified Body interactions for medical devices and IVDs.
Extensive experience with leading European Notified Bodies.
Proven success rate in first-time audit approvals.
Deep understanding of MDR and IVDR conformity assessment requirements.
Dedicated project management to coordinate all Notified Body interactions.
Flexible engagement models
from ad-hoc support to full outsourcing.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.