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Month: April 2023

Just Released: Updated Transitional Arrangements for UKCA Process

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On 28 April 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) published a communication updating previous information on the extension period for the mandatory implementation of the United Kingdom Conformity Assessment (UKCA) process for medical devices. This update is resultant from the recent amendment by the EU Commission (EU 2023/607) to extend the transition period for MDR 2017/745.

The New England Journal of Medicine: Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia

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Limflow, developer of the Limflow System for treatment of Chronic Limb-Threatening Ischemia (CLTI), partnered with NAMSA during this pertinent clinical study. With a dedicated focus on medical device and IVD products, NAMSA has designed and conducted trials in every area of the world to address wide-ranging client objectives. Our clinical experts are uniquely positioned to understand … Continued

AI Guidance for Medical Devices | NAMSA

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On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.