Innovative X-ray Technology ā€“ for Improved Breast Cancer Diagnosis

…x-ray imaging/ computer tomography, magnetic resonance tomography, ultrasound) are now online in the Company & Product category at http://www.medica-tradefair.com. New and approved approaches to oncological diagnosis and therapy will be…

…x-ray imaging/ computer tomography, magnetic resonance tomography, ultrasound) are now online in the Company & Product category at http://www.medica-tradefair.com. New and approved approaches to oncological diagnosis and therapy will be…

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

Surprise ā€“ Chief Jailable Officers Get Put in Jail

By Dr. Christopher Joseph Devine

…hefty sentences for fraud. Retrieved September 9, 2014, from http://www.meddeviceonline.com. United States v. Michael Baker and Michael Gluk Court Docket Number: 1:13-CR-00346-SS. (2014, August). Retrieved September 9, 2014, from http://www.justice.gov/criminal/vns/caseup/baker-gluk.html….

…hefty sentences for fraud. Retrieved September 9, 2014, from http://www.meddeviceonline.com. United States v. Michael Baker and Michael Gluk Court Docket Number: 1:13-CR-00346-SS. (2014, August). Retrieved September 9, 2014, from http://www.justice.gov/criminal/vns/caseup/baker-gluk.html….

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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

…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 26, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410467.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 26, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410467.htm…

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Japanā€™s Growth Strategy Promotes Medical and Healthcare Reform

By Ames Gross

…medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit www.pacificbridgemedical.com.  …

…medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia. For more information, visit www.pacificbridgemedical.com.  …

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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

Accelerating Device Development Against Current Product Development, Regulatory Landscape

By Sangita Viswanathan

…a third party manufacturer, we are a one-stop-shop; we can run this particular product for one week and then make a completely different product the following week. Larger companies can…

…a third party manufacturer, we are a one-stop-shop; we can run this particular product for one week and then make a completely different product the following week. Larger companies can…

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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

…Software works collaboratively with companies to deliver open solutions that help them turn more ideas into successful products. For more information on Siemens PLM Software products and services, visit www.siemens.com/plm. …

…Software works collaboratively with companies to deliver open solutions that help them turn more ideas into successful products. For more information on Siemens PLM Software products and services, visit www.siemens.com/plm. …

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

The Training Tradeoff ā€“ Trained Employees that Leave versus Untrained Employees that Remain

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 4, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm406826.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 4, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm406826.htm….

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