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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Haunting Consent Decree

By Dr. Christopher Joseph Devine

…Endoscope Reprocessors. (November 2015). Accessed November 17, 2015. Retrieved from http://www.fda.gov/Safety/Recalls/ucm472940.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery FDA. (June 2005). Inspections, Compliance, Enforcement, and Criminal Investigations. Custom Ultrasonics, Inc. Accessed November 17, 2015. Retrieved from http://www.fda.gov/iceci/enforcementactions/warningletters/2005/ucm075455.htmx…

…Endoscope Reprocessors. (November 2015). Accessed November 17, 2015. Retrieved from http://www.fda.gov/Safety/Recalls/ucm472940.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery FDA. (June 2005). Inspections, Compliance, Enforcement, and Criminal Investigations. Custom Ultrasonics, Inc. Accessed November 17, 2015. Retrieved from http://www.fda.gov/iceci/enforcementactions/warningletters/2005/ucm075455.htmx…

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Vague FDA Guidance Not Helping Cybersecurity Challenges

By Maria Fontanazza

…with companies to review documentation, server architecture and diagrams, and come up with full feature security review based on documentation. If a company doesn’t have this documentation or only limited…

…with companies to review documentation, server architecture and diagrams, and come up with full feature security review based on documentation. If a company doesn’t have this documentation or only limited…

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Engineering World Health, Biomedical trainers
Soapbox

Lack of Operational Medtech Equipment in Developing World

By Leslie Calman, Ph.D., Jessica Baker

…who can understand what a particular device is for or how it works, sometimes even new equipment is left uninstalled, taking up hospital space and helping no one. First- and…

…who can understand what a particular device is for or how it works, sometimes even new equipment is left uninstalled, taking up hospital space and helping no one. First- and…

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Xiaomi Mi Band

Wearable Medical Device Trends in the Asian Markets

By Ames Gross

…spanning from U.S.-based Fitbit and Jawbone, Japan’s Omron, Spain’s Nuubo and China’s Xiaomi, comprise just a few players in this field. Competition is rising as Asian consumers and corporations pay…

…spanning from U.S.-based Fitbit and Jawbone, Japan’s Omron, Spain’s Nuubo and China’s Xiaomi, comprise just a few players in this field. Competition is rising as Asian consumers and corporations pay…

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American Diabetes Month: Fast Stats about the Disease

By Maria Fontanazza

…adults in the United States will have diabetes by 2050. Diabetes complications include heart attack, kidney failure, vision loss, limb amputation. Figure courtesy of AdvaMed. 1 in 9 healthcare dollars…

…adults in the United States will have diabetes by 2050. Diabetes complications include heart attack, kidney failure, vision loss, limb amputation. Figure courtesy of AdvaMed. 1 in 9 healthcare dollars…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

FDA a Pain in the Butt for Hemorrhoid Management System Establishment

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 27, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Ultroid Technologies, Inc. Accessed November 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463616.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 27, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Ultroid Technologies, Inc. Accessed November 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463616.htm…

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Alert

Dirty Endoscopes Dethrone Alarms as Biggest Health Tech Hazard

…to properly operate can lead ventilator-induced lung injuries Misuse of USB ports can cause medical device malfunction An executive brief of the report is available for download on ECRI’s website….

…to properly operate can lead ventilator-induced lung injuries Misuse of USB ports can cause medical device malfunction An executive brief of the report is available for download on ECRI’s website….

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

I Am Not Aware of a Quality System: Seriously?

…guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 5, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations….

…guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 5, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations….

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Holst Centre, Eindhoven, Electronics

Smaller Electronics Push Possibility of Wearable Devices

By Maria Fontanazza

…is developing a medical-grade wearable for pregnancy and prenatal care. Headquartered in San Francisco, the two-year-company has created a technology that provides instant feedback 100 times faster than comparable technology,…

…is developing a medical-grade wearable for pregnancy and prenatal care. Headquartered in San Francisco, the two-year-company has created a technology that provides instant feedback 100 times faster than comparable technology,…

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