Search Results for ICDs

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ICD and Pacemaker Ecosystems Vulnerable to Hacks: Report By Michael Mezher - Published 05 June 2017

Cybersecurity firm WhiteScope says it has identified cybersecurity vulnerabilities in the device ecosystems for pacemakers and implantable cardioverter-defibrillators (ICDs) across four major vendors.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Pacemakers, ICDs, Billy Rios, WhiteScope, DHS ICS-CERT

FDA Warns Abbott Device Manufacturing Plant in California By Zachary Brennan - Published 13 April 2017

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.

Categories: News, US, FDA, Due Diligence, Medical Devices, Quality

Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds