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

Dr. D is Mean Spirited, Seriously?

By Dr. Christopher Joseph Devine

…no such thing as minimum or maximum compliance, there is only compliance!” That being said, the Dr. D has occasionally thrown FDA under the bus, when the doctor believes they…

…no such thing as minimum or maximum compliance, there is only compliance!” That being said, the Dr. D has occasionally thrown FDA under the bus, when the doctor believes they…

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FDA

FDA Announces Cybersecurity Public Workshop

By MedTech Intelligence Staff

…frameworks leveraged for benchmarking an organization’s processes) which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved…

…frameworks leveraged for benchmarking an organization’s processes) which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved…

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Chaotic Moon, Tech Tat, electronic tattoo

Wearables: Are Tech Tats Next?

By MedTech Intelligence Staff

…take up a lot of room and space. https://www.youtube.com/watch?v=9iFuTaqD4fM What do you think: Is the tech tat too futuristic to be taken seriously or is it a potentially viable technology?…

…take up a lot of room and space. https://www.youtube.com/watch?v=9iFuTaqD4fM What do you think: Is the tech tat too futuristic to be taken seriously or is it a potentially viable technology?…

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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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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

…in turn increasing the overall risk of a security breach. Medical devices are increasingly becoming more complex and part of larger systems, adding to the challenges that product architects face….

…in turn increasing the overall risk of a security breach. Medical devices are increasingly becoming more complex and part of larger systems, adding to the challenges that product architects face….

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