Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
As ‍ ‌‍ ‍‌ ‍ ‌‍ ‍‌ data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
Some of the most challenging leakage-current-testing requirements are those for patient-monitoring devices—both invasive and noninvasive. Such testing can be time-consuming and expensive, so it is ...
The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for violations of current good manufacturing practices (CGMP). Additionally, ...
Glaucoma is a leading cause of blindness worldwide, with the greatest burden in low- and middle-income countries (LMICs) where access to diagnostic services is limited. Portable devices, which are ...