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Devine Guidance

FDA Issues a Warning Letter with no Plant Inspection! What?

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March24, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438226.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March24, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm438226.htm….

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Certified Quality PLM Solutions

…are not only understood but met, and we strive to exceed your expectations. Leadership – Leaders at Siemens PLM establish unity in purpose and direction. Company leaders inspire, encourage, and…

…are not only understood but met, and we strive to exceed your expectations. Leadership – Leaders at Siemens PLM establish unity in purpose and direction. Company leaders inspire, encourage, and…

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Boston Scientific wins CE Mark and FDA Approval for Thinner, Leadless ICD

By MedTech Intelligence Staff

…earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the EMBLEM device in the US.” For more information on the S-ICD System visit www.sicdsystem.com….

…earlier than expected FDA approval, and will immediately begin preparations for a mid-year launch of the EMBLEM device in the US.” For more information on the S-ICD System visit www.sicdsystem.com….

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

What About the Reports?

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436701.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March16, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436701.htm….

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EU Notified Body Unannounced Audits and Your Suppliers

By Richard Vincins

In September 2013, the European Commission published the recommendation On the Audits and Assessments Performed by Notified Bodies in the Field of Medical Devices. The full recommendation can be found…

In September 2013, the European Commission published the recommendation On the Audits and Assessments Performed by Notified Bodies in the Field of Medical Devices. The full recommendation can be found…

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Engage Early to Get Product to Market on Time

Bioness, a U.S.-based medical device company, is focused on developing products to help individuals around the world with neurological impairments regain their independence. The company contracted with D&K Engineering, a…

Bioness, a U.S.-based medical device company, is focused on developing products to help individuals around the world with neurological impairments regain their independence. The company contracted with D&K Engineering, a…

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

Refusing an FDA Request Will Always End Badly!

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March10, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm434867.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March10, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm434867.htm….

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

Receiving Inspection ā€“ Not Much Value; However…

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March1, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2015, February). FDA.gov Website. Retrieved March1, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433248.htm….

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SGS Launches LinkedIn Life Sciences Community

…resources readily available in one place, we make it easier for life sciences organizations to get their products and services to market quickly and safely. Visit www.linkedin.com/company/sgs-life-sciences for more information….

…resources readily available in one place, we make it easier for life sciences organizations to get their products and services to market quickly and safely. Visit www.linkedin.com/company/sgs-life-sciences for more information….

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

Reprocessing Warning

By Dr. Christopher Joseph Devine

…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s safety alerts page. (2015, February). FDA.gov Website. Retrieved February 21, 2015, from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htmsource=govdelivery&utm_medium=email&utm_source=govdelivery….

…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s safety alerts page. (2015, February). FDA.gov Website. Retrieved February 21, 2015, from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htmsource=govdelivery&utm_medium=email&utm_source=govdelivery….

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