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

FDA Cites Failure to Assess Product Risk in Warning Letter

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 10, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Transdermal Cap, Inc. Accessed September 1, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458008.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 10, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Transdermal Cap, Inc. Accessed September 1, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458008.htm…

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The intersection of complaint handling, risk management and postmarket surveillance in the medical device industry

The Integration of Complaint Handling and Risk Management

By Roberta Goode, Julie Cabezas

…do this in a compliant way, let’s start with the regulations that require risk management and complaint handling activities. Complaint Handling Regulations The requirements for complaint handling are fairly straightforward….

…do this in a compliant way, let’s start with the regulations that require risk management and complaint handling activities. Complaint Handling Regulations The requirements for complaint handling are fairly straightforward….

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

Endoscopes, Too Little and Too Late

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 12, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Fujifilm Medical Systems U.S.A., Inc., Warning Letter….

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 12, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Fujifilm Medical Systems U.S.A., Inc., Warning Letter….

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Kenneth Fine, president and cofounder of Proven Process

Obamacare and Great User Expectations Hit Device Design

By Maria Fontanazza

…designs, while also trying to reduce component counts; identify common components; ensure that anything custom can actually be manufactured; and identify where in the world we’re going to actually make…

…designs, while also trying to reduce component counts; identify common components; ensure that anything custom can actually be manufactured; and identify where in the world we’re going to actually make…

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Four Reasons to Use Additive Manufacturing in Medical Device Development

By Ron Belknap

…August 12, 2015. Retrieved from http://dupress.com/articles/additive-manufacturing-3d-opportunity-in-medtech/ Did You Know, Additive Manufacturing for Medical, Bioprinting and Drug Discovery. Accessed August 12, 2015. Retrieved from http://www.additivemanufacturingmedical.com/ “Toward Isotropically Tough 3D Printed Biomedical…

…August 12, 2015. Retrieved from http://dupress.com/articles/additive-manufacturing-3d-opportunity-in-medtech/ Did You Know, Additive Manufacturing for Medical, Bioprinting and Drug Discovery. Accessed August 12, 2015. Retrieved from http://www.additivemanufacturingmedical.com/ “Toward Isotropically Tough 3D Printed Biomedical…

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Asia

Demand Skyrockets for Oncology Products in Asian Markets

By Ames Gross

…of cancers. Both lifestyle cancers that are associated with the wealthy as well as infection-based cancers that mainly affect the poor are common across Asia. Out of all cancer cases…

…of cancers. Both lifestyle cancers that are associated with the wealthy as well as infection-based cancers that mainly affect the poor are common across Asia. Out of all cancer cases…

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UL LLC

Ask the Expert: EU Regulations and Clarification for Products Used in Day Spas

…used in the workplace to be certified to recognized standards. You can read more on the standards that apply to Beauty Therapy products in the UL white paper at: http://library.ul.com/?document=safety-of-personal-hygiene-beauty-therapy-equipment-used-in-commercial-settings…

…used in the workplace to be certified to recognized standards. You can read more on the standards that apply to Beauty Therapy products in the UL white paper at: http://library.ul.com/?document=safety-of-personal-hygiene-beauty-therapy-equipment-used-in-commercial-settings…

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How to CE Mark a Medical Device that Incorporates a Drug

By Paula McCarthy

…consult a Competent Authority before taking a decision on providing CE Mark certification. The manufacturer must compile a comprehensive dossier clearly describing the quality, safety and usefulness of the drug…

…consult a Competent Authority before taking a decision on providing CE Mark certification. The manufacturer must compile a comprehensive dossier clearly describing the quality, safety and usefulness of the drug…

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Could the Pope Give You a Heart Attack?

By Maria Fontanazza

Those who have been in the presence of the pope often describe the experience as deeply emotional and quite overwhelming. But could these feelings actually cause a heart attack? Probably…

Those who have been in the presence of the pope often describe the experience as deeply emotional and quite overwhelming. But could these feelings actually cause a heart attack? Probably…

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

Only Two Form 483 Observations Can Equate to a Warning Letter

By Dr. Christopher Joseph Devine

…take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint…

…take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint…

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