On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.
The drafted guidance is...
The healthcare industry is known for rapidly adopting advanced technologies that offer improved treatment for various diseases. Consequently, digital twin technology in healthcare has gained popularity during the past few years, owing to the range of advantages it offers.
Digital twin technology...
In a highly regulated industry like medical technology, manufacturing processes must undergo either process verification or process validation to ensure they’re consistently producing the correct result. The question is, which one should you use?
Verification and validation are two different...
Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.
The trend is not fading away...
