Japanese market, MedTech Intelligence

How to Succeed in Japan’s Medical Device Market

By Ames Gross

…a period of time. When this happens, it is possible that competitors will spread the news that the product cannot be sold in Japan until the re-registration process is complete,…

…a period of time. When this happens, it is possible that competitors will spread the news that the product cannot be sold in Japan until the re-registration process is complete,…

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

Endoscopes, Too Little and Too Late

By Dr. Christopher Joseph Devine

…manufacture endoscopes that continue to make national news over reprocessing issues that have resulted in serious patient illnesses and a handful of patient fatalities. As many of the readers already…

…manufacture endoscopes that continue to make national news over reprocessing issues that have resulted in serious patient illnesses and a handful of patient fatalities. As many of the readers already…

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Could the Pope Give You a Heart Attack?

By Maria Fontanazza

…said Pamela Alpin, Sales Manager at HeartSine Technologies, in a news release. While it is important that these potentially life-saving devices are available in public places, proper training is recommended…

…said Pamela Alpin, Sales Manager at HeartSine Technologies, in a news release. While it is important that these potentially life-saving devices are available in public places, proper training is recommended…

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

If Hackers Can Commandeer a Car, Why not a Medical Device?

By Dr. Christopher Joseph Devine

…of providing the first three paragraphs from the agency’s news release. The culprit associated with this news release is the Hospira Symbiq Infusion System. Unfortunately, this was not the first…

…of providing the first three paragraphs from the agency’s news release. The culprit associated with this news release is the Hospira Symbiq Infusion System. Unfortunately, this was not the first…

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Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com

Communicating Device Issues to Patients? Align Your Message

By Maria Fontanazza

…through a variety of outlets (colleagues, news media, industry meetings, and device manufacturer reps), but the extent to which FDA communicates doesn’t go far enough beyond a notification letter, according…

…through a variety of outlets (colleagues, news media, industry meetings, and device manufacturer reps), but the extent to which FDA communicates doesn’t go far enough beyond a notification letter, according…

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

Heigh-Ho, Heigh-Ho, It’s Off to Jail You Go

By Dr. Christopher Joseph Devine

…Part 820 Compliance. Charleston, SC: Amazon. OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides. (June 2016). FDA News Release. Accessed June 30, 2015. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452987.htm…

…Part 820 Compliance. Charleston, SC: Amazon. OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides. (June 2016). FDA News Release. Accessed June 30, 2015. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452987.htm…

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Rosemary Weghorst, Managing Director, Berkeley Research Group LLC

The OIG Work plan: Potential Implications for Medical Device Manufacturers and Suppliers

By Rosemary Weghorst

…Research Group, LLC or its other employees and affiliates. Reference 1. Johnson, D. (2014 November 13).“Hospitals Pocketing Taxpayer Cash for Free Devices.” The Washington Times. Retrieved from: http://www.washingtontimes.com/news/2014/nov/13/golden-hammer-hospitals-pocketing-cash-for-free-de/#ixzz3c16ZylrG    …

…Research Group, LLC or its other employees and affiliates. Reference 1. Johnson, D. (2014 November 13).“Hospitals Pocketing Taxpayer Cash for Free Devices.” The Washington Times. Retrieved from: http://www.washingtontimes.com/news/2014/nov/13/golden-hammer-hospitals-pocketing-cash-for-free-de/#ixzz3c16ZylrG    …

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Devine Guidance

Bigler v. Olympus & Virginia Mason Medical Center

By Dr. Christopher Joseph Devine

…wishes for continued professional success. References Allecia, J. (2015, March). Widow sues Virginia Mason; hospital begins notifying ‘superbug’ victims. Retrieved May 19, 2015, from http://www.seattletimes.com/seattle-news/health/widow-sues-virginia-mason-hospital-begins-notifying-superbug-victims/ Code of Federal Regulation. (2014,…

…wishes for continued professional success. References Allecia, J. (2015, March). Widow sues Virginia Mason; hospital begins notifying ‘superbug’ victims. Retrieved May 19, 2015, from http://www.seattletimes.com/seattle-news/health/widow-sues-virginia-mason-hospital-begins-notifying-superbug-victims/ Code of Federal Regulation. (2014,…

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

Audit Your Own Area, Receive a Warning Letter!

By Dr. Christopher Joseph Devine

…matters audited. The dates and results of quality audits and reaudits shall be documented.” Compliance for Dummies The doctor would like to begin the compliance piece with some good news….

…matters audited. The dates and results of quality audits and reaudits shall be documented.” Compliance for Dummies The doctor would like to begin the compliance piece with some good news….

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

The United States of America v. Medtronic., a corporation, and S. Omar Ishrak and Thomas M. Teft, individuals

By Dr. Christopher Joseph Devine

…deficiencies have been adequately corrected. The bad news for the CFO(s) is that the cap on fines is currently set at $10 million for each calendar year. That is clearly…

…deficiencies have been adequately corrected. The bad news for the CFO(s) is that the cap on fines is currently set at $10 million for each calendar year. That is clearly…

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