FDA officials are warning that medical device shortages could worsen now that the public health emergency has expired because with its end a requirement for medical device companies to notify the ...
In September 2022, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) began hearing from patients and clinicians about difficulties obtaining pediatric ...
Some medical device supply chain challenges at hospitals are foundational such as determining what they own and establishing a comprehensive inventory. Medical devices are one of the most challenging ...
When it comes to semiconductor device testing, the primary goal is to ensure that each device meets functional and performance specifications. Testing also plays a crucial role in confirming that ...
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...
This article is a condensed version of an article that appeared in the November/December 2022 issue of Chip Scale Review. Adapted with permission. Read the original ...
Distributors, dispensers, and retailers of medical device products face a patchwork of federal and state requirements governing distribution chain compliance. Given the evolving and expanding ...
The medical device industry faces unprecedented complexity as regulatory frameworks continue to evolve while technological capabilities expand exponentially. As we progress through 2025, manufacturers ...
This allows for the verification of device trustworthiness and the establishment of a stable communication environment. DONO VAULT has adopted blockchain layer rollup technology, which enables ...
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release. Dr.
The old-school model of a medical device manufacturing supply chain just doesn’t cut it anymore. Todd Martensen ought to know. He’s been in the medical and life sciences business for 35 years, the ...