Autoinjector

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

By Erin Davis, Allison Strochlic

…be prone to the same user interaction issues upon commercialization. Usability testing. If the device developer conducted one or more usability tests, review the usability testing approach, including each test’s…

…be prone to the same user interaction issues upon commercialization. Usability testing. If the device developer conducted one or more usability tests, review the usability testing approach, including each test’s…

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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

…limits, operating parameters and component inputs A specific catalog of data which should be recorded or analyzed while conducting tests, calibration and validation Certain tests that should be performed to…

…limits, operating parameters and component inputs A specific catalog of data which should be recorded or analyzed while conducting tests, calibration and validation Certain tests that should be performed to…

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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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Peter Rose, Maetrics
Soapbox

A Smooth Route to the New Medical Device Regulation

By Peter Rose

With the guiding aim of bringing about a “robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a very high level of safety and health whilst supporting…

With the guiding aim of bringing about a “robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a very high level of safety and health whilst supporting…

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China flag

Chinaā€™s Proposed Regulatory Updates

By Ames Gross

…it is developed under a compulsory license. China’s National Health and Family Planning Commission plans to issue more detailed information on the compulsory license process and more clearly define what…

…it is developed under a compulsory license. China’s National Health and Family Planning Commission plans to issue more detailed information on the compulsory license process and more clearly define what…

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

Fail to Document Rework and Bad Things Happenā€”Ask FDA

By Dr. Christopher Joseph Devine

component on a printed circuit board (PCB), the rework will probably involve some level of board or system test to ensure the rework was properly completed. However, depending upon the…

component on a printed circuit board (PCB), the rework will probably involve some level of board or system test to ensure the rework was properly completed. However, depending upon the…

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Ameing for Asia

Case Study: Sourcing Medical Supplies in India and Vietnam

By Ames Gross

…capable of producing all of the required components. The manufacturers were all expecting to procure or source components from other companies in order to fulfill the requirements. Of course, this…

…capable of producing all of the required components. The manufacturers were all expecting to procure or source components from other companies in order to fulfill the requirements. Of course, this…

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

No Control

By Dr. Christopher Joseph Devine

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Oxford Performance Materials. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557872.htm….

…of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Oxford Performance Materials. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm557872.htm….

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3M adhesive

Ouch! Adhesives Should Protect, Not Hurt, the Skin

By Maria Fontanazza

…We hear it over and over again from component manufacturers that OEMs come to them too late, when they’ve already made the decision on the type of component and the…

…We hear it over and over again from component manufacturers that OEMs come to them too late, when they’ve already made the decision on the type of component and the…

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