The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

The Master of Engineering (M.Eng.) in Medical Device Development is a cutting-edge program that promises to accelerate the career development of aspiring engineers in all disciplines who wish to pivot ...

I clearly remember standing in the operating room (OR). I was there with our sales representative to observe a case as part of our normal Voice of Customer (VOC) process. I had seen well over 50 ...

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 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, ...

Given that medical devices are becoming increasingly complex, it is often hard for developers to stay op to date with evolving real-world parameters (human factors) and regulatory standards. Moreover, ...

STEMart announces the expansion of its genetic toxicology capabilities with the In Vivo Rat Micronucleus Test services.

ProMed, a contract manufacturer specializing in liquid silicone rubber (LSR) and highly regulated combination products, has announced new process refinements in the LSR injection molding process ...