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New Frontiers for Medical Tourism in Asia

By Ames Gross

…Thailand, Singapore and Japan: Expanding Specializations As a world-renowned vacation destination, Thailand offers medical tourists a combination of warm and sandy beaches, inspiring temples and 44 Joint Commission International (JCI)-accredited…

…Thailand, Singapore and Japan: Expanding Specializations As a world-renowned vacation destination, Thailand offers medical tourists a combination of warm and sandy beaches, inspiring temples and 44 Joint Commission International (JCI)-accredited…

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Elizabeth Brown
Reimbursement Report

Critical Marketing Considerations for Medical Technologies

By Elizabeth Brown, MD

…adoption of medical technologies may also be driven by convenience and a competitive advantage, but physicians will likely be sensitive to how a new technology, such as a new office-based…

…adoption of medical technologies may also be driven by convenience and a competitive advantage, but physicians will likely be sensitive to how a new technology, such as a new office-based…

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

Fail to Respond to Form 483 Observations and Win a Warning Letter

By Dr. Christopher Joseph Devine

…a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed November 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm…

…a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed November 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473657.htm…

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Diabetes management

Big Data Meets Diabetes

By Maria Fontanazza

…highly competitive, with Medtronic Diabetes, Roche Diabetes Care, Animas Corp., Tandem Diabetes Care, Inc., and Smiths Medical being among the key players. Although device companies commonly consider human factors into…

…highly competitive, with Medtronic Diabetes, Roche Diabetes Care, Animas Corp., Tandem Diabetes Care, Inc., and Smiths Medical being among the key players. Although device companies commonly consider human factors into…

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

Bad Clinicians

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (2012). Clinical Investigators – Disqualification Proceedings. Accessed November 21, 2015. Retrieved: http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (2012). Clinical Investigators – Disqualification Proceedings. Accessed November 21, 2015. Retrieved: http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm….

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Technology hazards in hospirals, ECRI

Solving Technology Hazards in Hospitals

By Maria Fontanazza

…multidisciplinary committee as opposed to selecting one person or group from a specific area of expertise in the healthcare facility. “The committees should involve nursing, administration, the medical community, engineering,…

…multidisciplinary committee as opposed to selecting one person or group from a specific area of expertise in the healthcare facility. “The committees should involve nursing, administration, the medical community, engineering,…

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Nicholas Daniell, Sunrise Labs
Soapbox

Robust Security Planning Requires Change in Mindset

By Nicholas Daniell

…optimized for the computing power available to the device. For example, it may be difficult for smaller devices to perform complex cryptography. If this is an absolute requirement, it might…

…optimized for the computing power available to the device. For example, it may be difficult for smaller devices to perform complex cryptography. If this is an absolute requirement, it might…

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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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