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Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.
The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
Come meet our team at Pure Global and discover how we can help with your regulatory questions and help you gain market access for your device.
An event focusing on regulatory aspects, attracting professionals from around the world to discuss the latest trends and regulations.
One of the largest medical B2B trade fairs globally, showcasing products and services across medical imaging, diagnostics, health IT, and more.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
