Adhesive

Understanding and Overcoming Challenges of Medical Adhesives

By Bret Ludwig, Ph.D.

…non-woven backing based on its appearance and feel. The company completed multiple internal wear studies before testing whether the backing was compatible with the thermal-bonding technique their manufacturing group desired…

…non-woven backing based on its appearance and feel. The company completed multiple internal wear studies before testing whether the backing was compatible with the thermal-bonding technique their manufacturing group desired…

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Ameing for Asia

Four Reasons to Source and Manufacture Medical Supplies in Asia

By Ames Gross

…products across the Asian region, and a strong interest in lowering Western medtech product costs, growing opportunities to make and source medtech products and components in Asia shouldn’t come as…

…products across the Asian region, and a strong interest in lowering Western medtech product costs, growing opportunities to make and source medtech products and components in Asia shouldn’t come as…

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Alert

Following Reported Deaths, FDA Issues Alert on Intragastric Balloons

By MedTech Intelligence Staff

…received two more reports of death that are related to complications associated with the balloon treatment—one occurred as a result of gastric perforation and the other esophageal perforation. “The FDA…

…received two more reports of death that are related to complications associated with the balloon treatment—one occurred as a result of gastric perforation and the other esophageal perforation. “The FDA…

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Emmanuel Garnier, Simmons & Simmons LLP
Soapbox

When Health-Related Apps Qualify as Medical Devices in the European Union

By Emmanuel Garnier

…or when this action is limited to storage, archiving, communication, simple search or lossless data compression, it cannot be described as a medical device. Conversely, for the Advocate General, if…

…or when this action is limited to storage, archiving, communication, simple search or lossless data compression, it cannot be described as a medical device. Conversely, for the Advocate General, if…

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

Is Dr. D on Your Approved Supplier’s List?

By Dr. Christopher Joseph Devine

…that require validation of the process to manufacture the part/component. For example, parts/components have undergone processes such as injection molding, anodization and powder coating at the supplier and you do…

…that require validation of the process to manufacture the part/component. For example, parts/components have undergone processes such as injection molding, anodization and powder coating at the supplier and you do…

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Cybersecurity, mhealth

Protecting Networks and Rapidly Treating Patients a Balance in Cybersecurity

By MedTech Intelligence Staff

…are focused on more than just compliance and threat management but also on the business value cyber can bring to the new approaches, models and capabilities that drive healthcare.” KPMG’s…

…are focused on more than just compliance and threat management but also on the business value cyber can bring to the new approaches, models and capabilities that drive healthcare.” KPMG’s…

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Autoinjector

Optimize Combination Products: Select a Platform Drug Delivery Device that Reflects Good Human Factors Engineering

By Erin Davis, Allison Strochlic

…HFE comprehensively during device development. Request documentation of the activities that could serve as a starting point for the new combination product’s documentation and design history file. Confirm that the…

…HFE comprehensively during device development. Request documentation of the activities that could serve as a starting point for the new combination product’s documentation and design history file. Confirm that the…

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Medtronic Avalus aortic valve

Double Win: Medtronic Receives FDA Approval and CE Mark for Aortic Valve

By MedTech Intelligence Staff

This week Medtronic announced it received both the CE Mark and FDA approval for its Avalus pericardial aortic surgical valve. The company touts it as the only stented surgical aortic…

This week Medtronic announced it received both the CE Mark and FDA approval for its Avalus pericardial aortic surgical valve. The company touts it as the only stented surgical aortic…

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Checkbox

IQ, OQ and PQ: The Backbone of Your Quality System

By Edward Simpson

…that it delivers consistent results with predetermined standards of quality. This article details the importance of each component. Installation Qualification (IQ) To validate whether new equipment is capable of delivering…

…that it delivers consistent results with predetermined standards of quality. This article details the importance of each component. Installation Qualification (IQ) To validate whether new equipment is capable of delivering…

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Mona Orady
Soapbox

We Need to Come Together to Learn Complex Surgery

By Mona Orady, M.D.

…our efficiency. Interactive learning produces this important knowledge. I’ve watched as surgeons at all levels avoid complications by learning from someone in a completely different area of medicine. Coming together…

…our efficiency. Interactive learning produces this important knowledge. I’ve watched as surgeons at all levels avoid complications by learning from someone in a completely different area of medicine. Coming together…

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