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Additive Manufacturing Collaboration Brings 3D-Printed Arms to Kids Worldwide

By MedTech Intelligence Staff

…where 3D printing innovations are happening. We have an established nucleus of faculty performing cutting-edge biomedical engineering research, says Michael Georgiopoulos, dean of UCF’s College of Engineering and Computer Science….

…where 3D printing innovations are happening. We have an established nucleus of faculty performing cutting-edge biomedical engineering research, says Michael Georgiopoulos, dean of UCF’s College of Engineering and Computer Science….

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Who’s Liable for 3-D Printed Medical Devices?

By Maria Fontanazza

…a lot of liability questions, said Michael Bruyere, attorney at Freeman Mathis & Gary LLP, at the Inside 3D Printing Conference and Expo in New York City. Who will be…

…a lot of liability questions, said Michael Bruyere, attorney at Freeman Mathis & Gary LLP, at the Inside 3D Printing Conference and Expo in New York City. Who will be…

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Clinical Data from OUS Studies Get Guidance From FDA

By Maria Fontanazza

…device submissions. It is worth noting that this is not a new FDA policy. The agency is simply proving more insight on the issue. Once final, the guidance will offer…

…device submissions. It is worth noting that this is not a new FDA policy. The agency is simply proving more insight on the issue. Once final, the guidance will offer…

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Devine Guidance

Chief Jailable Officers Indicted for Adulteration and Misbranding of Medical Devices

By Dr. Christopher Joseph Devine

…for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Former Acclarent, Inc. executives charged with securities fraud and crimes related…

…for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. Former Acclarent, Inc. executives charged with securities fraud and crimes related…

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J&J Sags in Medical Device, Still Plans to Launch 30 Products by 2016

By MedTech Intelligence Staff

…the new products that we’re launching.” Some of this optimism comes from shedding the Cordis business, which the company sees as a commodity business at this point, and holding on…

…the new products that we’re launching.” Some of this optimism comes from shedding the Cordis business, which the company sees as a commodity business at this point, and holding on…

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FDA’s New Program Puts Life-Saving Technologies on Fast Track to Approval

By Maria Fontanazza

Today FDA introduced a voluntary program that will help manufacturers reduce time and money in getting certain life-saving devices to market, while still complying with FDA’s standards for assuring safety…

Today FDA introduced a voluntary program that will help manufacturers reduce time and money in getting certain life-saving devices to market, while still complying with FDA’s standards for assuring safety…

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Three Mistakes That Can Kill Your Time to Market

By Dan Baril

…production processes that significantly shorten new product development cycles is essential to optimizing business potential. Start-up companies that miss VC-required milestones, or R&D groups in larger organizations facing market pressure…

…production processes that significantly shorten new product development cycles is essential to optimizing business potential. Start-up companies that miss VC-required milestones, or R&D groups in larger organizations facing market pressure…

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

You Gotta Validate Design Changes!

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 4, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Verichem Laboratories, Inc. Accessed April 7, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 4, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Verichem Laboratories, Inc. Accessed April 7, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm…

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Reimbursement Report

What Manufacturers Should Know About Reimbursement and Case Management Hotlines for Providers

By Kristofer C. Munroe

…science companies and manufactures should be aware of FAQ #10, because it is an example of challenges facing life science companies and manufacturers. It shows how one state law that…

…science companies and manufactures should be aware of FAQ #10, because it is an example of challenges facing life science companies and manufacturers. It shows how one state law that…

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