FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR requirements govern “the methods used ...
If you’re a medical device inventor, developer, or start-up with an innovative medical device idea, choosing the perfect medical device contract manufacturer is essential to the success of your ...
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 ...
Whether developing a new device or improving an existing one, STEMart has the experience to help clients address the design, engineering, manufacturing and regulatory challenges unique to the medical ...
Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...
Way back in 2001, MD+DI published an article detailing what the author considered to be The Seven Deadly Sins of Medical Device Development. The author reviewed dozens of device development programs ...
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 ...
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 ...
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