Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
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.
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.