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

…on cybersecurity reiterates the point that medtech manufacturers must comply with QSRs There’s a need to involve all stakeholders in the healthcare ecosystem and engage in upfront communication with the…

…on cybersecurity reiterates the point that medtech manufacturers must comply with QSRs There’s a need to involve all stakeholders in the healthcare ecosystem and engage in upfront communication with the…

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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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GI tract

Gastrointestinal Diseases Rise in Asia

By Ames Gross

…purchased an undisclosed stake in Frankenman Medical Equipment Company, a Chinese company based in Suzhou. Frankenman Medical specializes in producing surgical devices, including surgical staplers, and suction and irrigation systems….

…purchased an undisclosed stake in Frankenman Medical Equipment Company, a Chinese company based in Suzhou. Frankenman Medical specializes in producing surgical devices, including surgical staplers, and suction and irrigation systems….

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

Smile!

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. CrystalBraces, LLC. Accessed January 19, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478989.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (October 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. CrystalBraces, LLC. Accessed January 19, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478989.htm…

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FDA

FDA Encouraging Manufacturers to Proactively Prepare for Cybersecurity Vulnerabilities

By MedTech Intelligence Staff

…document, “Postmarket Management of Cybersecurity in Medical Devices”, specifies how companies should proactively plan for and evaluate security gaps in consistency with the quality system regulation, along with encouraging information…

…document, “Postmarket Management of Cybersecurity in Medical Devices”, specifies how companies should proactively plan for and evaluate security gaps in consistency with the quality system regulation, along with encouraging information…

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