Insulet, OmniPod

Beyond Diabetes, Insulet Explores Viable Smart Drug Delivery

By Maria Fontanazza

…applications for several years. Expansion within the combination products realm involves investigating a complex set of competencies, from device-drug compatibility to ensuring precise drug delivery within a specific timeframe. In…

…applications for several years. Expansion within the combination products realm involves investigating a complex set of competencies, from device-drug compatibility to ensuring precise drug delivery within a specific timeframe. In…

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Soapbox

Want to Be a Medical Device Entrepreneur?

By Scott Phillips

…Eventually he was able to persuade a small company, Edwards Laboratories, to make them commercially. From there, Fogarty founded 33 medical device companies and a venture capital company while maintaining…

…Eventually he was able to persuade a small company, Edwards Laboratories, to make them commercially. From there, Fogarty founded 33 medical device companies and a venture capital company while maintaining…

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

Bayer’s New Headache

By Dr. Christopher Joseph Devine

…Retrieved from http://www.dgplaw.com/blog/2016/02/essure-medical-device-health-problems.html Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013). Devine guidance for

…Retrieved from http://www.dgplaw.com/blog/2016/02/essure-medical-device-health-problems.html Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Devine, C. (2013). Devine guidance for

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CAPA risk gateway

Your CAPA System: Operate Effectively and Maintain Profitability

By Ken Peterson

…strict guidelines enforced by the FDA and other global regulatory bodies. Medical device companies are obligated to meet market demands while fully complying with regulatory requirements. Over the last several…

…strict guidelines enforced by the FDA and other global regulatory bodies. Medical device companies are obligated to meet market demands while fully complying with regulatory requirements. Over the last several…

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Accenture, patient analytics

Boston Scientific and Accenture Leverage Digital Health for Cardiovascular Patients

By MedTech Intelligence Staff

…and patient engagement (how patients are educated, monitored and communicated with during and after their time in the hospital). The companies plan to expand the digital health solution to other…

…and patient engagement (how patients are educated, monitored and communicated with during and after their time in the hospital). The companies plan to expand the digital health solution to other…

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Cybersecurity

Cybersecurity: Protecting Interconnected Devices from Intrusion ‘Vital’, says FDA’s Ostroff

By Maria Fontanazza

…advantage of and leverage the knowledge and expertise of the entire cyber research community and many others.” During the workshop, experts discussed the following key points related to cybersecurity: Cybersecurity…

…advantage of and leverage the knowledge and expertise of the entire cyber research community and many others.” During the workshop, experts discussed the following key points related to cybersecurity: Cybersecurity…

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FDA

FDA Helps Manufacturers Address Security and Risk of Interoperable Medical Devices

By MedTech Intelligence Staff

…and device labeling. “Interoperability refers to the ability of medical devices to interact with other medical devices and systems, including electronic health record systems, and to communicate with each other…

…and device labeling. “Interoperability refers to the ability of medical devices to interact with other medical devices and systems, including electronic health record systems, and to communicate with each other…

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

More Truths in Advertising

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Sonic Life.com, LLC. Accessed January 23, 2016.Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478988.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Sonic Life.com, LLC. Accessed January 23, 2016.Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478988.htm…

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