Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be ...
Where is the best place to locate manufacturing to minimize supply chain risk, maintain a low cost of goods sold, and ...
In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software ...
While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances ...
FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 ...
Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of ...
In a year characterized by both unprecedented challenges and groundbreaking advancements, the medtech industry continues to demonstrate its resilience and capacity for innovation. Faced with the ...
The EU AI Act (Regulation (EU) 2024/1689) is a landmark legislation that will shape the future of AI in Europe and is expected to be the baseline for similar legislation in other countries/regions. It ...
Growing up in a family deeply rooted in medicine, I had a unique perspective on the field. My grandparents attended Meharry Medical College, and my parents met while studying at Howard University ...
Smart implants, embedded with sensors, represent the future of healthcare by enabling real-time monitoring and response capabilities. These devices include pacemakers, neurostimulators, and orthopedic ...
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