Vulnerability sharing arms stakeholders with the information they need to assess devices, minimize cybersecurity risks and proactively mitigate emerging risks to prevent exploitation.
Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.
It is the first federal approval for a test that uses saliva as the primary test biomaterial for COVID-19.
A lot of promises are made by organizations about making systems more intuitive, convenient and user-centric, but in reality most improvements tend to be designed to meet regulatory or internal system needs rather than better serve the people who use them. The user experience needs to be modernized, especially in heavily regulated industries where inaccurate or non-compliant labeling is laden with risk.
Timely compliance will ensure that your products will not be considered misbranded.
In the face of the coronavirus pandemic, the surge in demand for ventilators may push the market to surpass $5.2 billion.
With the Covid-19 pandemic increasingly forcing healthcare testing, diagnosis and treatment online, the promise of augmented and virtual reality is drawing deepening interest in Asia’s medtech market.
Medtech companies often struggle to connect to their in-hospital devices in real time due to challenges with hospital network connectivity. Now, more than ever, reliable network connectivity is essential. And the solution lies with a new use of radio technology.
The researchers speculate that they have about two weeks to “get it right” and scale up to meet the surge of patients expected to enter hospitals.
The system will allow healthcare professionals to reuse the critical care products up to 20 times during the COVID-19 pandemic.