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Regulation and Research: Navigating the Landscape of Medical Devices in Europe and the U.S.

Regulation and Research: Navigating the Landscape of Medical Devices in Europe and the U.S.

by Allen Curreri | Jan 13, 2025 | Diagnostic Aids, Health, Medical Technology

The medical device industry is a rapidly evolving sector where innovation meets rigorous regulatory oversight. Companies aiming to introduce devices to the European and U.S. markets must navigate two distinct regulatory landscapes: the European Union’s Medical Device...
Regulation and Research in Medical Devices: Comparing Europe and the U.S.

Regulation and Research in Medical Devices: Comparing Europe and the U.S.

by Allen Curreri | Nov 8, 2024 | Diagnostic Aids, Health, Medical Technology

The medical device industry operates under rigorous regulations in Europe and the United States to ensure that devices are safe, effective, and trustworthy. Despite their shared goals, the regulatory landscapes in Europe and the U.S. differ significantly, each with...
How Correct Regulation Helps Mitigate the Risks of Wearable Medical Devices

How Correct Regulation Helps Mitigate the Risks of Wearable Medical Devices

by Allen Curreri | Oct 1, 2024 | Diagnostic Aids, Health, Medical Technology

Wearable medical devices are transforming healthcare by providing real-time monitoring, diagnosis, and even treatment for various health conditions. From smartwatches that track heart rates to continuous glucose monitors for people with diabetes, these devices promise...
The Best Wellness Applications of Medical Devices

The Best Wellness Applications of Medical Devices

by Allen Curreri | Sep 3, 2024 | Health, Medical Technology

In recent years, medical technology advancements have revolutionized how we approach health and wellness. Medical devices, once primarily used in clinical settings, are now becoming integral to everyday health management, offering personalized insights and helping...
How the EU Is Governing AI for Medical Devices

How the EU Is Governing AI for Medical Devices

by Allen Curreri | Aug 5, 2024 | Diagnostic Aids, Health, Medical Technology

The European Union (EU) is leading in regulating artificial intelligence (AI), particularly in the sensitive field of medical devices. With the rapid advancement of AI technology, concerns about patient safety, data privacy, and ethical implications have grown. The EU...
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