4 QFD Tips for Emerging Medical Device Technology

…ensure your company is taking on the appropriate level of risk and reward with its emerging medical device technology. Striking a balance of customer ignorance and customer input is a…

…ensure your company is taking on the appropriate level of risk and reward with its emerging medical device technology. Striking a balance of customer ignorance and customer input is a…

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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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It’s Not About Faster Approvals, but About Better Availability, says FDA Commissioner Hamburg

By Sangita Viswanathan

…2014 annual conference in Chicago this week FDA Commissioner Dr. Margaret Hamburg referred to some progress made by the agency in shortening approval timelines and in creating new processes for

…2014 annual conference in Chicago this week FDA Commissioner Dr. Margaret Hamburg referred to some progress made by the agency in shortening approval timelines and in creating new processes for

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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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When Heart Valves Come from a Printer

By Klaus Jopp

…small and light. Along these lines, the British company Accutronics is showing a new development at COMPAMED 2014 that has just been awarded a £ 100,000 prize by the United…

…small and light. Along these lines, the British company Accutronics is showing a new development at COMPAMED 2014 that has just been awarded a £ 100,000 prize by the United…

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Reimbursement Report

PMA Approval and Third-Party Reimbursement

By Elizabeth Brown, MD

…reimbursement is clearly the final goal. Without it, commercialization stalls. The following blog is the second in a series of posts that examines the relationship between reimbursement and the type…

…reimbursement is clearly the final goal. Without it, commercialization stalls. The following blog is the second in a series of posts that examines the relationship between reimbursement and the type…

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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 – Eight Month’s to Scrap Nonconforming Product – 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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