Sue Niemeier, Ivenix
MEDdesign

When Accuracy and Flow Don’t Add Up: The Case for New Design in Large Volume Pumps

By Susan Niemeier, MHA, BSN, RN

…performance and patient response in a real-world setting, where various environmental factors may dramatically affect flow rate accuracy. We need a fundamentally new paradigm in infusion pump engineering and design…

…performance and patient response in a real-world setting, where various environmental factors may dramatically affect flow rate accuracy. We need a fundamentally new paradigm in infusion pump engineering and design…

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

When Furry Critters Aren’t So Cute

By Dr. Christopher Joseph Devine

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Dr. D’s enforcement page. (February 2016). DGII Website. Accessed March 27, 2018. Retrieved from http://www.devineguidanceinternational.com

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Dr. D’s enforcement page. (February 2016). DGII Website. Accessed March 27, 2018. Retrieved from http://www.devineguidanceinternational.com

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FDA

FDA Allows Marketing of First Interoperable Continuous Glucose Monitoring System

By MedTech Intelligence Staff

…click on each story for the update. You can also sound off in the comments section. Think this is the fake news? Wrong! Here’s our April Fool’s story. https://medtechintelligence.com/column/when-furry-critters-arent-so-cute/  …

…click on each story for the update. You can also sound off in the comments section. Think this is the fake news? Wrong! Here’s our April Fool’s story. https://medtechintelligence.com/column/when-furry-critters-arent-so-cute/  …

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Rice University, Diabetic foot

Device Helps Patients Detect Early Signs of Ulceration

By MedTech Intelligence Staff

…and click on each story for the update. You can also sound off in the comments section. Think this is the fake news? Wrong! Here’s our April Fool’s story. https://medtechintelligence.com/column/when-furry-critters-arent-so-cute/…

…and click on each story for the update. You can also sound off in the comments section. Think this is the fake news? Wrong! Here’s our April Fool’s story. https://medtechintelligence.com/column/when-furry-critters-arent-so-cute/…

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Medical device recall

BD Recalls Vacutainer Blood Collection Tubes Due to Chemical Interference

By MedTech Intelligence Staff

Last week BD announced a Class I recall of its Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers. A chemical in the stopper interferes…

Last week BD announced a Class I recall of its Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers. A chemical in the stopper interferes…

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Daniel R. Matlis, Axendia
Soapbox

Why Is Quality Focusing on Compliance?

By Daniel R. Matlis

…loop allows quality and compliance events to influence the product engineering cycle in a timely fashion. 85% of respondents indicated the primary role of quality is ensuring compliance 10% of…

…loop allows quality and compliance events to influence the product engineering cycle in a timely fashion. 85% of respondents indicated the primary role of quality is ensuring compliance 10% of…

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Japan

Japan a Major Player, But Be Prepared

By Maria Fontanazza

…the second largest single country medical device market in the world,” says Gross. “Also, Japan has a very developed medical community, so Western companies with new technologies will normally find…

…the second largest single country medical device market in the world,” says Gross. “Also, Japan has a very developed medical community, so Western companies with new technologies will normally find…

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Alert

Failing to Properly Clean, Disinfect and Sterilize Devices Among Top Patient Hazards

By MedTech Intelligence Staff

Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…

Medical device reprocessing is a common practice in hospitals and other healthcare facilities. The practice can save costs and prevent more waste from entering landfills. However, when devices are not…

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Theranos

SEC Charges Theranos CEO Elizabeth Holmes with Fraud, Stripped of Control of Company

By MedTech Intelligence Staff

…could only complete a small number of tests. In fact, “the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” according to…

…could only complete a small number of tests. In fact, “the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others,” according to…

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Brian Moan, Norman Rabin, Maetrics
Soapbox

IVDR signals In Vitro Industry Shake-up

By Brian Moan, Norman Rabin

…the new regulation addresses the flaws and contributes further to improving patient safety. The introduction of the new IVDR means that medical device companies are going to need to re-evaluate…

…the new regulation addresses the flaws and contributes further to improving patient safety. The introduction of the new IVDR means that medical device companies are going to need to re-evaluate…

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