by Allen Curreri | Jul 8, 2025 | Uncategorized
For innovators in the medical device space, understanding regulatory frameworks is just as critical as breakthrough technology. If you’re launching a device, one of the most complex puzzles you’ll face is navigating the regulatory landscape—and it changes dramatically...
by Allen Curreri | Jun 6, 2025 | Uncategorized
The medical device industry operates in a highly regulated environment, especially in regions like the United States and Europe. Manufacturers must adhere to strict standards to ensure product safety, efficacy, and quality before entering the market. However, the...
by Allen Curreri | May 9, 2025 | Uncategorized
Bringing a medical device to market is no small feat — and the path looks very different depending on where you’re headed. For companies eyeing both the U.S. and European markets, understanding the nuances between the regulatory frameworks is not just helpful, it’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...
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...
