How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
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Search Results for: cybersecurity
Illumina to Pay $9.8M Over Cybersecurity Vulnerabilities in Genomic Sequencing Systems
Illumina has agreed to pay $9.8 million after allegations that its genomic sequencing systems sold to federal agencies contained cybersecurity vulnerabilities.
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FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
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White Paper Offers Best Practices for Medical Imaging Cybersecurity
The document outlines common imaging device outage scenarios and manufacturers’ recommended steps to mitigate the impact and keep systems functioning.
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‘Dirty Data’ Undermines a Generation of AI Cybersecurity Tools, Study Finds
While 9 in 10 security leaders feel prepared for an attack, a new “trust gap” report finds only 25% actually trust their own data, leading to slow remediation and delays in AI adoption.
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