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

Duodenoscopes Take Two

By Dr. Christopher Joseph Devine

…820 Compliance. Charleston, SC: Amazon. FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm. FDA. (March 2018)….

…820 Compliance. Charleston, SC: Amazon. FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm. FDA. (March 2018)….

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Alert

Olympus, Fujifilm and Pentax Warned by FDA for Compliance Failures

By MedTech Intelligence Staff

…30. “If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties,” FDA stated. https://medtechintelligence.com/news_article/pentax-medical-recalls-certain-duodenoscopes/  …

…30. “If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties,” FDA stated. https://medtechintelligence.com/news_article/pentax-medical-recalls-certain-duodenoscopes/  …

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Bang Chau, Innovit

Embrace the Healthcare Data Transformation

By Bang Chau

community is by adopting healthcare industry standards such as: GS1, HBICC or ISBT for product identification GDSN for synchronization of supply chain and commercial data HL7/SPL for submitting UDI and…

community is by adopting healthcare industry standards such as: GS1, HBICC or ISBT for product identification GDSN for synchronization of supply chain and commercial data HL7/SPL for submitting UDI and…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Strategies for Success in Japan’s Medical Device Market

By Ames Gross

…whether these companies were qualified. The impetus for choosing this Japanese trading company was the fact that this trading company was going to invest $5 million in the client’s company,…

…whether these companies were qualified. The impetus for choosing this Japanese trading company was the fact that this trading company was going to invest $5 million in the client’s company,…

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FDA

Abbott Wins FDA Approval for World’s Smallest Mechanical Heart Valve

By MedTech Intelligence Staff

…a new treatment option for pediatric patients. “While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants,…

…a new treatment option for pediatric patients. “While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants,…

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Rich Denness, North Highland
Soapbox

Turning Internal Challenges into Customer Opportunities

By Rich Denness

…2018: Healthcare and Life Sciences. In North Highland. Retrieved from http://www.northhighland.com/insights/thought-leadership/north-highland-beacon-healthcare Shah, S. (2017, August 31). FDA recalls close to half-a-million pacemakers over hacking fears. In Engadget. Retrieved from https://www.engadget.com/2017/08/31/fda-pacemakers-abbott-hacking/…

…2018: Healthcare and Life Sciences. In North Highland. Retrieved from http://www.northhighland.com/insights/thought-leadership/north-highland-beacon-healthcare Shah, S. (2017, August 31). FDA recalls close to half-a-million pacemakers over hacking fears. In Engadget. Retrieved from https://www.engadget.com/2017/08/31/fda-pacemakers-abbott-hacking/…

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Optical imaging, rice university

Wearable Microscopes Could Eliminate Biopsies and Blood Tests

By MedTech Intelligence Staff

…by Vivek Boominathan/Rice University) The technology will use computational scatterography, a combination of mathematical algorithms, camera design and imaging sensors that will allow them to reverse engineer the scattered light…

…by Vivek Boominathan/Rice University) The technology will use computational scatterography, a combination of mathematical algorithms, camera design and imaging sensors that will allow them to reverse engineer the scattered light…

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Emmanuel Garnier, Simmons & Simmons LLP

Medtech Companies Must Prepare for Brexit Now

By Emmanuel Garnier

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must…

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must…

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

Seriously, No Audits Performed Since 2015?

By Dr. Christopher Joseph Devine

…an inspection; having to worry about the basics (e.g., internal audits) just adds to their angst. Remember, having observation-free inspections, commences with the instauration(look-it-up) of a compliant QMS. Enjoy! Warning…

…an inspection; having to worry about the basics (e.g., internal audits) just adds to their angst. Remember, having observation-free inspections, commences with the instauration(look-it-up) of a compliant QMS. Enjoy! Warning…

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Nathan Muller, StarFish Medical
MEDdesign

Biomaterials: Overview and Design Considerations

By Nathan MĂźller

Biomaterials have become a byword in recent years. Emerging technological advancement and research has led to an explosion in the availability and variety of biomaterials. Accompanying these new materials, there…

Biomaterials have become a byword in recent years. Emerging technological advancement and research has led to an explosion in the availability and variety of biomaterials. Accompanying these new materials, there…

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