Noticias2024-06-26T09:32:29+00:00

Noticias y novedades

Hemodialysis bloodlines shortage: FDA alert and clinical implications

marzo 21, 2025|

The U.S. Food and Drug Administration (FDA) has recently issued a communication to healthcare providers regarding an ongoing shortage of hemodialysis bloodlines, a critical component in both acute and chronic dialysis treatments. These devices, responsible for connecting a patient’s [...]

Conditional CE certificates: A new pathway for faster market access?

marzo 17, 2025|

Over the past few years, the medical device industry has been navigating a complex regulatory landscape with the implementation of MDR 2017/745 and IVDR 2017/746. While these regulations have strengthened safety and performance standards, they have also created a bottleneck [...]

Data integrity in medical device testing – A critical FDA concern

marzo 14, 2025|

Why data integrity in medical device testing is more important than ever The FDA’s Center for Devices and Radiological Health (CDRH) has recently intensified its scrutiny of data integrity in medical device testing, and for good reason. The agency has [...]

AI and medical devices: The UK defines a new regulatory path

marzo 12, 2025|

Artificial Intelligence is transforming the healthcare industry, providing increasingly sophisticated tools for diagnosis, monitoring, and treatment. However, with the rising adoption of AI-powered medical devices, ensuring safety and effectiveness has become a top priority. Recently, the UK government took [...]

New recall procedures in Australia: what changes with PRAC?

marzo 10, 2025|

March 5, 2025, marked a significant step forward in the regulation of medical device recalls in Australia. The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC), replacing the previous Uniform Recall Procedure [...]

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