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

Buyers Beware!

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, August). FDA.gov Website. Retrieved August 31, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410035.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, August). FDA.gov Website. Retrieved August 31, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410035.htm….

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

Who Wants Clean Air and Water?

By Dr. Christopher Joseph Devine

…everything a device establishment procures. Please use some common sense and apply a risk-based approach. For example, if the material composition for a catheter marker band is deemed critical, it…

…everything a device establishment procures. Please use some common sense and apply a risk-based approach. For example, if the material composition for a catheter marker band is deemed critical, it…

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Japan’s Growth Strategy Promotes Medical and Healthcare Reform

By Ames Gross

…for Western medical companies in Asia’s largest healthcare market. An example of a mixed medical treatment would be combining anti-cancer drugs that have not been approved in Japan with approved…

…for Western medical companies in Asia’s largest healthcare market. An example of a mixed medical treatment would be combining anti-cancer drugs that have not been approved in Japan with approved…

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

Design Changes Often Require FDA Scrutiny!

By Dr. Christopher Joseph Devine

…that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture,…

…that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture,…

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Ask the Engineer

Ask the Expert: Silicone Tubing

…The industries have tubing needs involving flexibility, performance, the absence of animal-derived ingredients and cost that are common to many applications. The following questions address two critical requirements involving silicone…

…The industries have tubing needs involving flexibility, performance, the absence of animal-derived ingredients and cost that are common to many applications. The following questions address two critical requirements involving silicone…

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Ask the Engineer

Accelerating Device Development Against Current Product Development, Regulatory Landscape

By Sangita Viswanathan

…doing it? Kaminski: A lot of the new devices being developed now are being done by start-ups or smaller companies that don’t have all the in-house resources to produce product….

…doing it? Kaminski: A lot of the new devices being developed now are being done by start-ups or smaller companies that don’t have all the in-house resources to produce product….

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

Manufacturers of Class I and Class II Exempt Devices Still Require a QMS

By Dr. Christopher Joseph Devine

…exempt require establishments to: (a) maintain an effective recordkeeping system; (b) comply with product labeling requirements (Part 801); (c) establish a system for the management of complaints; and (d) comply…

…exempt require establishments to: (a) maintain an effective recordkeeping system; (b) comply with product labeling requirements (Part 801); (c) establish a system for the management of complaints; and (d) comply…

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Recognizing the Value of PLM in Health Sciences

…saving opportunities to companies that understand the risks of adopting any new technology and implementing it properly. But companies looking to introduce the next new innovation (such as customer relationship…

…saving opportunities to companies that understand the risks of adopting any new technology and implementing it properly. But companies looking to introduce the next new innovation (such as customer relationship…

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Executives Offer Prospects for Med-Tech Business Model

By Daniel R. Matlis

…visibility across a Supply Chain has always been integration and communication. Companies need to develop better systems and processes that support that. Mark Lincoln As organizations continue to focus more…

…visibility across a Supply Chain has always been integration and communication. Companies need to develop better systems and processes that support that. Mark Lincoln As organizations continue to focus more…

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Reimbursement Report

The Appeals Process

By Elizabeth Brown, MD

…non-covered, out-of-pocket health care costs. This practice seriously undermines the ability to demonstrate physician acceptance of a technology and reverberates beyond simple coverage. For example, the CPT advisory committee will…

…non-covered, out-of-pocket health care costs. This practice seriously undermines the ability to demonstrate physician acceptance of a technology and reverberates beyond simple coverage. For example, the CPT advisory committee will…

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