This is the second alert the agency has issued in less than one year.
Why does anyone want to hack a medical device or steal medical data? The risk may appear low, but unfortunately this is not the case.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
When applicable, the process provides novel products with a speedier route to market.
There are too many unique needs on the part of both manufacturers and providers. More collaboration is needed.
Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies.
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
How software is changing the legal landscape for medical device manufacturers.
A manufacturing error could cause chamber parts to split into layers and cause water to back up into the patient breathing circuit.
SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.