Sharing more information with design partners on device function and its inherent risks can help guide better decisions during the product development process, and keep patients safer.
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.
Managing suppliers is critical, and your processes in doing so must be documented.
ECRI releases its top 10 list of health technology hazards for 2018.
The agency clarifies some misconceptions about requirements.
No medical device is 100% secure.
A three-part series on quality system remediation and what manufacturers need to do to get through the process.
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
If exploited, unauthorized access to these devices could have dangerous consequences.
Device manufacturers need to identify, monitor and address cybersecurity vulnerabilities as part of postmarket device management.