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

If an Activity or Event is not ā€œDocumentedā€ in Writing, in the Eyes of FDA, it Didn’t Happen!

By Dr. Christopher Joseph Devine

…service performed; and The test and inspection data. Compliance for Dummies Dr. D would like to start with the comment, it is a pretty difficult task to comply with §820.200(b);…

…service performed; and The test and inspection data. Compliance for Dummies Dr. D would like to start with the comment, it is a pretty difficult task to comply with §820.200(b);…

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

It is not Nice (or Smart) to Anger FDA!

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, September). FDA.gov Website. Retrieved October 20, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418141.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved October 20, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418141.htm….

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Compliance Management for Medical Devices

…an enterprise, including its PDF, XML, J2EE-compliant web applications and back-end data sources. The Teamcenter architecture also reflects Siemens PLM Software’s commitment to “green” product development. By designing environment compliance…

…an enterprise, including its PDF, XML, J2EE-compliant web applications and back-end data sources. The Teamcenter architecture also reflects Siemens PLM Software’s commitment to “green” product development. By designing environment compliance…

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

What is the Point of CAPA if the Establishment Fails to Fix Problems?

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, September). FDA.gov Website. Retrieved October 13, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416625.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved October 13, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm416625.htm….

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

A Misbranded Bed; is that Even Possible?

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, September). FDA.gov Website. Retrieved September 30, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415503.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved September 30, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415503.htm….

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What Changes Should Manufacturers Expect From FDA?

…their Quality Systems are compliant and consistent with the type of work they do. The other area the FDA is focusing on is changing the conversation from just compliance to…

…their Quality Systems are compliant and consistent with the type of work they do. The other area the FDA is focusing on is changing the conversation from just compliance to…

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

Surprise ā€“ Eight Monthā€™s to Scrap Nonconforming Product ā€“ Seriously?

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, September). FDA.gov Website. Retrieved September 30, 2014, From: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415733.htm….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved September 30, 2014, From: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415733.htm….

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Ames Gross, Pacific Bridge Medical

Medical Device Companies Look East

By Ames Gross

…together established a Breast Health Resource Center in Shanghai. Common cancer treatments in China include radiation, surgery and chemotherapy, in addition to combination treatments. There are some cancer treatment centers…

…together established a Breast Health Resource Center in Shanghai. Common cancer treatments in China include radiation, surgery and chemotherapy, in addition to combination treatments. There are some cancer treatment centers…

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

Surprise ā€“ Device Establishments are Required to Pursue Acceptance Activities ā€“Who Knew?

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, September). FDA.gov Website. Retrieved September 20, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved September 20, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/….

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What Can Apps Do For Health?

By MedTech Intelligence Staff

…about MEDICA 2014 exhibitors, product information, company news and the accompanying conferences and forum programs (for example MEDICA HEALTH IT FORUM and MEDICA CONNECTED HEALTH FORUM), are available at http://www.medica-tradefair.com….

…about MEDICA 2014 exhibitors, product information, company news and the accompanying conferences and forum programs (for example MEDICA HEALTH IT FORUM and MEDICA CONNECTED HEALTH FORUM), are available at http://www.medica-tradefair.com….

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