Latest Articles
Items shown: 9
Supply chain requirements for Economic Operators under the EU IVDR
Inadequate supply chain controls are a leading cause of non-conformities in Notified Body Technical Documentation Assessments under the IVDR. In this article, Dr. Oliver Eikenberg discusses how manufacturers should assess and update their supply chain agreements to ensure Economic Operator roles and obligations are clearly defined in line with IVDR requirements.
Clinical Evidence under IVDR: what is an “adequate level” for IVD manufacturers?
Conformity under the IVDR requires a rigorous approach to clinical evidence quality. In this article, Dr. Oliver Eikenberg explains the importance of performance evaluation processes and documentation to ensure adequate clinical evidence for EU IVDR compliance.
Engaging a Notified Body under the IVDR: What legacy manufacturers need to know about the pre-application process
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.
Regulatory requirements and challenges for new and old Class D devices under IVDR
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.
Intended purpose for IVDs and impact on the classification under IVDR
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.
Why and How EU IVDR Compliance Matters before the May 2025 Deadline
Many IVD and legacy IVD device manufacturers are obligated to comply with certain aspects of the IVDR even before their transition deadline. In this article, Oliver Eikenberg discusses how IVD companies can maintain EU compliance during the transition period.
Adapting your QMS to IVDR requirements until May 2025: what manufacturers need to know
The official IVDR transition period is here. IVDR expert Dr. Oliver Eikenberg discusses how IVD manufacturers should take action, starting with how to implement IVDR QMS requirements for the May 2025 deadline.
MDA Updates at IMDEC 2024: Paving the Way for Regulatory Excellence and Innovation in Medical Technology
Pure Global participated in IMDEC 2024 in Kuala Lumpur to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. Highlights included updates from the Malaysian Medical Device Authority (MDA) that showcased their commitment to driving regional leadership in medical device regulation and innovation.
Pure Global 2024: A Year of Growth, Innovation, and Global Impact
As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
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