Kevin Becker, Spectralytics
MEDdesign

Working with Your Component Manufacturer to Mitigate Risk

By Kevin Becker

…leaves the component manufacturer in the dark. Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer…

…leaves the component manufacturer in the dark. Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer…

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MedTech intelligence

Privacy Policy

…gdprrequests@foodsafetytech.com gdprrequests@medtechintelligence.com gdprrequests@foodsafetytech.com. Disclaimer of liability: This website is compiled and maintained with the utmost care. Nevertheless, we cannot guarantee the accuracy, completeness and freedom of errors of the data…

…gdprrequests@foodsafetytech.com gdprrequests@medtechintelligence.com gdprrequests@foodsafetytech.com. Disclaimer of liability: This website is compiled and maintained with the utmost care. Nevertheless, we cannot guarantee the accuracy, completeness and freedom of errors of the data…

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

Company Ignores FDA’s Request to Cease Commercial Distribution

By Dr. Christopher Joseph Devine

…(redacted) immediately cease activities that result in the misbranding or adulteration of the (redacted) software, such as the commercial distribution of the device for the uses discussed above.” Compliance for

…(redacted) immediately cease activities that result in the misbranding or adulteration of the (redacted) software, such as the commercial distribution of the device for the uses discussed above.” Compliance for

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Liver

Liver Disease: A Growing Problem in Asia

By Ames Gross

…Device firms are also making inroads in Asia with the production of diagnostic instruments. In January, Histoindex Pte, Ltd., a Singapore-based medical technology company, announced approval for a new digital…

…Device firms are also making inroads in Asia with the production of diagnostic instruments. In January, Histoindex Pte, Ltd., a Singapore-based medical technology company, announced approval for a new digital…

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Medtronic

Medtronic Recalls MindFrame Capture LP Revascularization Device

By MedTech Intelligence Staff

…bloodstream—and this issue and/or the attempt to remove the device could lead to complications that include bleeding, further blockage of blood vessels, more severe stroke symptoms or death. In the…

…bloodstream—and this issue and/or the attempt to remove the device could lead to complications that include bleeding, further blockage of blood vessels, more severe stroke symptoms or death. In the…

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Cybersecurity

Security for Connected Medical Devices

By John Turner

…numbers. https://www.securityfocus.com/news/11455 HIPAA Journal. Stolen Electromygraphy Device Contained 836 Patents PHI, says SSM Health. https://www.hipaajournal.com/stolen-electromyography-device-contained-836-patients-phi-says-ssm-health-8822/ Wikipedia. IEC 62304. https://en.wikipedia.org/wiki/IEC_62304 UL. FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices. https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/…

…numbers. https://www.securityfocus.com/news/11455 HIPAA Journal. Stolen Electromygraphy Device Contained 836 Patents PHI, says SSM Health. https://www.hipaajournal.com/stolen-electromyography-device-contained-836-patients-phi-says-ssm-health-8822/ Wikipedia. IEC 62304. https://en.wikipedia.org/wiki/IEC_62304 UL. FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices. https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/…

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FDA

FDA Publishes FDARA Mandated Report on Servicing of Medical Devices

By MedTech Intelligence Staff

…that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths)…

…that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths)…

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

Inspection Equipment not Qualified Equates to Problems with FDA!

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Dexcowin Co. Ltd.,…

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Dexcowin Co. Ltd.,…

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