A devices FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require ...

NovaPure components are West’s premium line of components developed and refined to provide the market with best-in-class levels of quality, performance, and risk mitigation. The brand includes ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...

Device functionality testing is an essential element of any medical device or drug delivery device development process. It is an essential part of design verification that demonstrates the developed ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

Pressures on healthcare systems are set to become worse with aging populations requiring round-the-clock care and an exponential increase in chronic diseases. Technology-led smart solutions are ...