Why MES Reduces the Pain of Audits
How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
Tag Archives: risk
A Security Epidemic: The Internet of (insecure) Things and the Risk to Medical Devices
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.
Working with Your Component Manufacturer to Mitigate Risk
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.
Security for Connected Medical Devices
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.
Risk-Based Purchasing Controls
Managing suppliers is critical, and your processes in doing so must be documented.
Patient Danger: Ransomware and Cybersecurity a Top Concern
ECRI releases its top 10 list of health technology hazards for 2018.
FDA Squashes Five Cybersecurity Myths
The agency clarifies some misconceptions about requirements.
It’s Impossible to Eliminate Cybersecurity Threat
No medical device is 100% secure.
Remediation: What Challenges Do Device Companies Face?
A three-part series on quality system remediation and what manufacturers need to do to get through the process.
FDA’s Guidance Clears Up Factors, Benefits and Risks for IDE Submissions
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
