Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical Devices… Lethal in Hands of Hackers” (The Hill) worry device manufacturers, doctors, and patients alike. These concerns are a direct result of an increasingly interconnected…
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ISO 14971

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing.
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FDA 483

Understanding Form FDA 483 Observations   The FDA conducts inspections on Class II and Class III medical device companies either for pre-approval before products are cleared for release, impromptu routine …
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Gap Analysis

Bridging the Gap between Good to Even Greater   All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such …
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