gavel

Medical Device Software & Products Liability: An Overview (Part I)

By Sara E. Dyson, Esq.

…$5.5 billion in 2014, but the increasing frequency of cyber attacks, regulatory and security compliance requirements, and data leaks have forced life sciences companies to dedicate more financial resources to…

…$5.5 billion in 2014, but the increasing frequency of cyber attacks, regulatory and security compliance requirements, and data leaks have forced life sciences companies to dedicate more financial resources to…

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Mike Kijewski, MedCrypt

The Medical Devices Most Vulnerable to Hackers

By Mike Kijewski

…could be inadvertently included in a “botnet,” using their computing resources to mine cryptocurrencies or take down a specific website. In conclusion, as healthcare moves further out of the hospital…

…could be inadvertently included in a “botnet,” using their computing resources to mine cryptocurrencies or take down a specific website. In conclusion, as healthcare moves further out of the hospital…

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

Failure to Conduct Audits is Going to End Badly!

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, August). FDA.gov Website. Retrieved September 08, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574275.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, August). FDA.gov Website. Retrieved September 08, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574275.htm…

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Ameing for Asia

Cloud Computing In Asia Is Growing

By Ames Gross

Cloud computing is one of the megatrends of the healthcare industry, as healthcare providers look for more efficient ways to collect, share, and analyze patient data. Cloud solutions are compatible…

Cloud computing is one of the megatrends of the healthcare industry, as healthcare providers look for more efficient ways to collect, share, and analyze patient data. Cloud solutions are compatible…

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Cybersecurity Vulnerability in Smith Medical Wireless Infusion Pumps

By MedTech Intelligence Staff

Register to attend the Medical Device Cybersecurity Workshop in person (Boston) or via webcast October 17–18, 2017 Learn moreA cybersecurity researcher identified eight vulnerabilities, ranging in severity from low to…

Register to attend the Medical Device Cybersecurity Workshop in person (Boston) or via webcast October 17–18, 2017 Learn moreA cybersecurity researcher identified eight vulnerabilities, ranging in severity from low to…

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Joachim Schaefer
Soapbox

Coming This Fall: Worldā€™s Largest MedTech Event

By Joachim SchƤfer

…development in the medical sector. A look back: Integrated, Digital Devices Among Top Technologies at MEDICA 2016A key example is in diagnostic applications for point-of-care testing. The equipment must function…

…development in the medical sector. A look back: Integrated, Digital Devices Among Top Technologies at MEDICA 2016A key example is in diagnostic applications for point-of-care testing. The equipment must function…

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Abbott

Cybersecurity: FDA Calls for Firmware Update on Abbottā€™s Pacemakers

By MedTech Intelligence Staff

…the patient’s physician) to access a patient’s device using commercially available equipment. This access could be used to modify programming commands to the implanted pacemaker, which could result in patient…

…the patient’s physician) to access a patient’s device using commercially available equipment. This access could be used to modify programming commands to the implanted pacemaker, which could result in patient…

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

No MDR Procedure: There is No Time Like the Present!

By Dr. Christopher Joseph Devine

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Whitehall/Div of Acorn Engineering Co. Accessed August 21, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm567734.htm…

…– 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Whitehall/Div of Acorn Engineering Co. Accessed August 21, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm567734.htm…

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Bob Ehlers, RGB Spectrum
MEDdesign

Trends in Video Technology for Medical Environments

By Bob Ehlers

…main video technologies and what works best for any situation. The demand for video surveillance has rapidly increased. With the introduction of megapixel cameras, companies are deploying 4K or Ultra…

…main video technologies and what works best for any situation. The demand for video surveillance has rapidly increased. With the introduction of megapixel cameras, companies are deploying 4K or Ultra…

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Dollar, money

Best Strategies for Distributor Search in China

By Ames Gross

…firms in China should aim to find distributors with recognizable names and national level market reach. The following are some examples: July 2017: Ortho Development Corporation (Drapper, UT), an orthopedic…

…firms in China should aim to find distributors with recognizable names and national level market reach. The following are some examples: July 2017: Ortho Development Corporation (Drapper, UT), an orthopedic…

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