Medical Device Cybersecurity, EU MDR and FDA Requirements Explained
Medical device cybersecurity has evolved from a technical concern into a core regulatory and patient safety requirement. As devices become increasingly connected, software driven and integrated with cloud infrastructure, cybersecurity risks now have direct implications for clinical outcomes. A vulnerability is no longer just an IT issue. It can affect device functionality, compromise diagnostic accuracy […]
US Medical Device Reimbursement Explained, Why Strategy Matters as Much as FDA Approval
Bringing a medical device to the United States market involves more than achieving regulatory clearance or approval. While FDA approval is often seen as the primary milestone, it does not guarantee commercial success. In practice, reimbursement determines whether a device will be adopted, used and financially viable. Without appropriate coverage, coding and payment, hospitals and […]
IVDR Transition Timeline Explained, What IVD Manufacturers Need to Do Now
The transition from the In Vitro Diagnostic Directive to the In Vitro Diagnostic Regulation represents one of the most significant regulatory shifts for diagnostic manufacturers in Europe. While the IVDR introduced stricter requirements for clinical evidence, quality systems and notified body oversight, the original transition timelines proved unworkable for much of the industry. As a […]
WHO Medical Device Policy Guidance: A Systemic Approach to Medical Device Ecosystems
The World Health Organisation (WHO) released the second edition of its policy guidance on the deployment of medical devices. This update represents a significant evolution from the first edition, moving away from a narrow focus on regulation and procurement toward a comprehensive medical device ecosystem framework. The guidance reflects changes in global health priorities, technological […]
FDA Investigational Device Exemption IDE: A Practical Guide to US Clinical Studies
An Investigational Device Exemption, commonly referred to as an IDE, is a critical regulatory mechanism that allows medical devices that are not yet cleared or approved to be used in clinical studies in the United States. The IDE framework enables manufacturers and sponsors to collect safety and effectiveness data while protecting study participants and maintaining […]
ISO 10993-1:2025 Explained, What Has Changed and What It Means for Manufacturers
ISO 10993-1 has long served as the foundational standard for the biological evaluation of medical devices. The 2025 revision represents a significant evolution in how biological safety is assessed, documented and integrated into overall device risk management. Rather than focusing on a checklist of biological tests, the updated standard formalises a lifecycle based, risk driven […]