Laura Johnson, Loftware
Soapbox

Emerging Trends and Opportunities in Medical Device Labeling

By Laura Johnson

…some new industry trends in labeling that are also providing unique opportunities for companies to reduce costs, save time, improve time to market (i.e., gain a competitive advantage). Here are…

…some new industry trends in labeling that are also providing unique opportunities for companies to reduce costs, save time, improve time to market (i.e., gain a competitive advantage). Here are…

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

Risk-Based Purchasing Controls

By Dr. Christopher Joseph Devine

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and…

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and…

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MedTech Intelligence

Cybersecurity: How Vulnerable Are You?

By MedTech Intelligence Staff

…many steps in the process–and there are many parties involved. Next month, cybersecurity experts from FDA, Battelle, Philips Healthcare, Johnson & Johnson, the Mayo Clinic and many other device companies…

…many steps in the process–and there are many parties involved. Next month, cybersecurity experts from FDA, Battelle, Philips Healthcare, Johnson & Johnson, the Mayo Clinic and many other device companies…

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Sue Niemeier, Ivenix
MEDdesign

When Accuracy and Flow Donā€™t Add Up: The Case for New Design in Large Volume Pumps

By Susan Niemeier, MHA, BSN, RN

…to ensure the highest quality patient care and safety. This starts with adaptive pump technology. An adaptive pump system automatically compensates for external factors that impact fluid delivery and will…

…to ensure the highest quality patient care and safety. This starts with adaptive pump technology. An adaptive pump system automatically compensates for external factors that impact fluid delivery and will…

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

When Furry Critters Arenā€™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

…the photo. Images are then transferred to the website via a special computer called an onboard Raspberry Pi computer. “It’s much easier than a manual device, like a mirror on…

…the photo. Images are then transferred to the website via a special computer called an onboard Raspberry Pi computer. “It’s much easier than a manual device, like a mirror on…

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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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