In an interview with TechNews180, Pure Global CEO Phyllis Meng discusses how AI and data analytics are revolutionizing market access and regulatory compliance for MedTech companies. Meng highlights Pure Global's platform, which provides seamless access to global registration data and clinical trial information, eliminating manual searches.
Pure Global's tracking of regulatory trends in over 100 countries offers clients strategic insights and helps them navigate complex multi-regional compliance. With local entities and expert representatives worldwide, Pure Global provides globally informed and locally applicable services, ensuring smooth operations and compliance in each jurisdiction. Looking ahead, Meng sees AI as a crucial technology for future market access and regulatory compliance services.
Read full article here.
Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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.
