Medical device recall

Modern Medicine: Managing Lithium-Ion Battery Recalls in Medical Devices

By Chris Harvey

…as well. Any time a recall crosses international boundaries, the complexity is compounded. That is especially true in the already complex case of lithium-ion batteries. Globally, organizations involved include the…

…as well. Any time a recall crosses international boundaries, the complexity is compounded. That is especially true in the already complex case of lithium-ion batteries. Globally, organizations involved include the…

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Dollar, money

North American TKR Market To Surpass $4 Billion by 2023

By MedTech Intelligence Staff

…soft tissue damage, and provides a faster recover period for patients. “Additionally, there is a case to be made for custom implants leading to fewer complications and potentially reducing post-acute…

…soft tissue damage, and provides a faster recover period for patients. “Additionally, there is a case to be made for custom implants leading to fewer complications and potentially reducing post-acute…

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Medtech question

Answers: Test Your ISO 13485 IQ Part II

By MedTech Intelligence Staff

…to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001. To be compliant with ISO 13485, purchased product from…

…to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001. To be compliant with ISO 13485, purchased product from…

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Change

Developing Medical Devices for Drugs and Alcohol Detoxification

By Vikram Tarugu, M.D.

…give credit where it is due, medical equipment developers are making commendable efforts to ensure detox patients undergo the least discomfort during withdrawal. A good example is a device known…

…give credit where it is due, medical equipment developers are making commendable efforts to ensure detox patients undergo the least discomfort during withdrawal. A good example is a device known…

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MEDICA

Focus on Digital Health, Future for Health Lab to Join MEDICA 2017

By MedTech Intelligence Staff

…first time. The FTR4H LAB will be located within the USA Pavilion, allowing U.S. companies to exhibit and highlight their latest technological advancements in the digital health space. The LAB…

…first time. The FTR4H LAB will be located within the USA Pavilion, allowing U.S. companies to exhibit and highlight their latest technological advancements in the digital health space. The LAB…

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Alert

Solution to Fatal Problem of Tubing Misconnections

By MedTech Intelligence Staff

With many manufacturers providing enteral feeding lines in different sizes and configurations, preventing tubing misconnections can be even more challenging. And the outcome can be deadly: For example, if a…

With many manufacturers providing enteral feeding lines in different sizes and configurations, preventing tubing misconnections can be even more challenging. And the outcome can be deadly: For example, if a…

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FDA

FDA to Hold Public Workshop on Cybersecurity and Regulatory Science

By MedTech Intelligence Staff

Next month FDA, in partnership with the National Science Foundation and the Department of Homeland Security, Science and Technology will hold a public workshop to look at opportunities to strengthen…

Next month FDA, in partnership with the National Science Foundation and the Department of Homeland Security, Science and Technology will hold a public workshop to look at opportunities to strengthen…

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

The Doghouse: DOJ Goes After Veterinary Devices

By Dr. Christopher Joseph Devine

Compliance. Charleston, SC: Amazon. FDA. (April 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. April 3, 2017: United States Department of Justice Press Release. Accessed April 10, 2017. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm550926.htm…

Compliance. Charleston, SC: Amazon. FDA. (April 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. April 3, 2017: United States Department of Justice Press Release. Accessed April 10, 2017. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm550926.htm…

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Elderly, medtech

Asia Aging Quickly, Many Medtech Opportunities

By Ames Gross

…Stryker have acquired local competitors in China to be able to sell the local companies’ “B-line” products with a Western label. If more Western companies do not create a “B…

…Stryker have acquired local competitors in China to be able to sell the local companies’ “B-line” products with a Western label. If more Western companies do not create a “B…

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BD, Becton Dickinson

BD to Acquire C.R. Bard for $24 Billion

By MedTech Intelligence Staff

…areas and OUS markets, including emerging markets. On the international front, Bard registered about 500 products internationally last year and the combined company is expected to generate $1 billion in…

…areas and OUS markets, including emerging markets. On the international front, Bard registered about 500 products internationally last year and the combined company is expected to generate $1 billion in…

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