How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
As medical technological capabilities increase along with the proliferation of embedded systems and IoT, cybersecurity is becoming a very real risk for the medical industry. While securing the whole medical device industry may seem like an insurmountable task, the combination of education, regulation and technology is a good first step toward protecting our most critical infrastructure from attack.
The agency is aiming to provide more transparency and consistency in this area.
As standards around interoperability emerge, now may be the time to look at the benefits of connected technologies.
The increase is significantly less than FY 2018, which saw user fees go up 33%.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
How simple labeling changes can drive big results for medical device manufacturers.
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.