Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.
Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website. This recognition highlights our unique position as the only global market access company listed, showcasing our expertise in helping businesses expand into China.
The BSP directory connects U.S. companies with trusted service providers who can navigate the complexities of the Chinese market. As a leading provider of global market access solutions, Pure Global offers tailored strategies to overcome trade barriers and drive sustainable growth for businesses worldwide.
To learn more, visit: China Business Service Providers on International Trade Administration.
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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.
