The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity ...
The FDA recently issued draft guidances for the use of AI in medical devices, drugs, and biologics. The guidances emphasize the need for comprehensive AI policies addressing risk evaluation, data ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...
The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
As cybersecurity threats have become more and more pressing in the healthcare industry in the last several years, FDA has taken several steps to strengthen the security of medical devices seeking ...
How would you grade your organization’s cybersecurity? A new report does just that, and the results are concerning for medical device companies. Overall, healthcare gets a passing B+, but medical ...
The new Medical Device Product Security Intelligence Platform from Medcrypt, of San Diego, CA, is designed to help medical device manufacturers (MDMs) evaluate their product's security posture, ...
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