The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...
Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...
As medical devices become increasingly more complex, the need to enhance development efficiency, quality by design, integrated risk management, and regulatory compliance has never been greater ...
Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...
Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use. To create ...
WOODBURY, Minn--(BUSINESS WIRE)--A first for the medical device development industry, I-Tek Medical, a Minneapolis, Minnesota based medical device contract manufacturing company, has joined forces ...
Why is it necessary to develop human resources for developing medical devices? Muragaki: Medical devices tend to be over-imported, with data for 2021 showing a trade deficit of 1.8 trillion yen. In ...
The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.
The FDA also issued guidance regarding clinical trials and medical devices that describes the agency's process for approving applications from companies that want to conduct clinical trials involving ...
OrthoPediatrics Corp. has announced its partnership with the Crossroads Pediatric Device Consortium (CPDC) to enhance the development of innovative pediatric medical devices. This multi-institutional ...
Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?
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