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

Device History Records and Rework

By Dr. Christopher Joseph Devine

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Medtronic Puerto Rico Operations Co. Accessed October 1, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619206.htm…

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Medtronic Puerto Rico Operations Co. Accessed October 1, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619206.htm…

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Technology hazards in hospirals, ECRI

For Second Year in a Row, Cybersecurity Issue Tops ECRI Health Tech Hazards List

By MedTech Intelligence Staff

…Seeping into Electrical Components Can Lead to Equipment Damage and Fires Flawed Battery Charging Systems and Practices Can Affect Device Operation View ECRI’s 2018 Top 10 Health Technology Hazards. https://medtechintelligence.com/news_article/testing-devices-critical-part-of-improving-patient-safety/…

…Seeping into Electrical Components Can Lead to Equipment Damage and Fires Flawed Battery Charging Systems and Practices Can Affect Device Operation View ECRI’s 2018 Top 10 Health Technology Hazards. https://medtechintelligence.com/news_article/testing-devices-critical-part-of-improving-patient-safety/…

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Abbas Dhilawala, Galen Data
MEDdesign

The Connected Economy: Opportunities and Barriers in Healthcare

By Abbas Dhilawala

…or applications. The benefits to the patient and provider are many, namely: Compliance and product impact. Compliance. One of the biggest opportunities with cloud-connected devices is patient compliance, which directly…

…or applications. The benefits to the patient and provider are many, namely: Compliance and product impact. Compliance. One of the biggest opportunities with cloud-connected devices is patient compliance, which directly…

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MEDICA

MEDICA to Showcase Trends in Interconnected Health and Mobile Aid

By Dr. Lutz Retzlaff

From intelligent prosthetics embedded with sensors to cuff-less blood pressure monitoring to smart patches, wearable technology continues to make leaps and bounds. This article briefly reviews a few examples of…

From intelligent prosthetics embedded with sensors to cuff-less blood pressure monitoring to smart patches, wearable technology continues to make leaps and bounds. This article briefly reviews a few examples of…

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Dollar, money

EY Report: Long-Term MedTech Growth at Risk, Companies Need to Invest in Digital, Consumer-Centric Capabilities

By Maria Fontanazza

…underway,” the authors state in the report. “Artificial intelligence is already sweeping through the sector and shaping a new generation of smart, robotic surgical devices.” The authors also warn companies…

…underway,” the authors state in the report. “Artificial intelligence is already sweeping through the sector and shaping a new generation of smart, robotic surgical devices.” The authors also warn companies…

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Chris Parsons, Critical Manufacturing

Why MES Reduces the Pain of Audits

By Chris Parsons

When a medtech company is audited by the FDA or any other regulatory body, it can be a long and expensive process. Rather than a focus on compliance, the FDA’s…

When a medtech company is audited by the FDA or any other regulatory body, it can be a long and expensive process. Rather than a focus on compliance, the FDA’s…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

High Demand for Breast Cancer Diagnosis and Treatment Products in Asia

By Ames Gross

…in the incidence of breast cancer and mortality from the disease, patients need a combination of cutting-edge screening techniques, diagnostic and therapeutic devices, and effective treatments to combat the disease….

…in the incidence of breast cancer and mortality from the disease, patients need a combination of cutting-edge screening techniques, diagnostic and therapeutic devices, and effective treatments to combat the disease….

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MDSAP, Medical Device Single Audit Program

You can do it! Nailing Your MDSAP Audit and Sustaining Long-Term Compliance

By Kate Leith

…in the 82-page MDSAP Audit Model. This comprehensive guide contains seven chapters and all 90 questions you will be asked during the audit. Perhaps the most helpful feature of this…

…in the 82-page MDSAP Audit Model. This comprehensive guide contains seven chapters and all 90 questions you will be asked during the audit. Perhaps the most helpful feature of this…

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Jothy Rosenberg, Dover Microsystems
MEDdesign

A Security Epidemic: The Internet of (insecure) Things and the Risk to Medical Devices

By Jothy Rosenberg

…to attacks. This fact, combined with processors that can’t defend themselves, makes software and those connected medical devices a ticking time bomb. Fortunately, there is hope. A combination of regulations,…

…to attacks. This fact, combined with processors that can’t defend themselves, makes software and those connected medical devices a ticking time bomb. Fortunately, there is hope. A combination of regulations,…

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Apple logo

Apple Watch 4 Gets FDA Clearance

By MedTech Intelligence Staff

In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event…

In addition to all the bells and whistles that come with an Apple Watch, the Series 4 product has received FDA clearance—specifically De Novo classification. Unveiled at an Apple event…

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