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

Class II Devices

By Dr. Christopher Joseph Devine

…this not earth-shattering news for the masses. So if Class I is low-risk and Class III is high-risk, then just maybe Class II is medium-risk (well, sort of). That is…

…this not earth-shattering news for the masses. So if Class I is low-risk and Class III is high-risk, then just maybe Class II is medium-risk (well, sort of). That is…

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Devine Guidance

Product Seizure

By Dr. Christopher Joseph Devine

…Significant Manufacturing Violations. (2007, April). FDA Website. Retrieved July 18, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108893.htm Rossetti, A. (2008, December). Shelhigh: anatomy of an FDA medical device product seizure. The Legal Examiner.  Retrieved…

…Significant Manufacturing Violations. (2007, April). FDA Website. Retrieved July 18, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108893.htm Rossetti, A. (2008, December). Shelhigh: anatomy of an FDA medical device product seizure. The Legal Examiner.  Retrieved…

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Devine Guidance

Identification & Traceability

By Dr. Christopher Joseph Devine

…upon material receipt. The good news is that most MRP systems have the capability of doing this upon receipt. Make sure that the Bill of Materials (BOMs) employed for assembling…

…upon material receipt. The good news is that most MRP systems have the capability of doing this upon receipt. Make sure that the Bill of Materials (BOMs) employed for assembling…

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MEDdesign

Cellular Phones Could Transform Global Healthcare

By Gunjan Bagla

…regulatory and physician acceptance issues are sorted out. And me? I’ve just ordered the uChek kit at the introductory price of $20. References: http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/ http://www.geekosystem.com/new-iphone-pee-tester-app/ http://uchek.in/index.html http://www.cnn.com/2012/09/28/opinion/mahmud-mobile-medic http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7Bc49b830e-33ba-467d-b066-94ce4c7a0f0c%7D/texts-improved-malaria-treatment-adherence-among-hcws-in-kenya http://healthmarketinnovations.org/program/medicallhome http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/…

…regulatory and physician acceptance issues are sorted out. And me? I’ve just ordered the uChek kit at the introductory price of $20. References: http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/ http://www.geekosystem.com/new-iphone-pee-tester-app/ http://uchek.in/index.html http://www.cnn.com/2012/09/28/opinion/mahmud-mobile-medic http://www.healio.com/infectious-disease/emerging-diseases/news/print/infectious-disease-news/%7Bc49b830e-33ba-467d-b066-94ce4c7a0f0c%7D/texts-improved-malaria-treatment-adherence-among-hcws-in-kenya http://healthmarketinnovations.org/program/medicallhome http://www.wired.com/business/2013/02/smartphone-becomes-smart-lab/…

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Devine Guidance

Not all Suppliers Need Audits

By Dr. Christopher Joseph Devine

Dr. D has some very good news for the readers. Medical device manufacturers are not required to audit their suppliers. But hey, if you do not believe the doctor, Dr….

Dr. D has some very good news for the readers. Medical device manufacturers are not required to audit their suppliers. But hey, if you do not believe the doctor, Dr….

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Devine Guidance

You Got a Warning Letter, Now What?

By Dr. Christopher Joseph Devine

…in a significant interruptions in the day-to-day activities of the recipients.   What happens next? The good news is that the U.S. Marshalls have not shown up at your establishment’s…

…in a significant interruptions in the day-to-day activities of the recipients.   What happens next? The good news is that the U.S. Marshalls have not shown up at your establishment’s…

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Devine Guidance

MHLW MO 169 – Chapter 4 – Manufacturing Control & Quality Control

By Dr. Christopher Joseph Devine

…What device manufacturers need to do As stated in the previous section, the Seihin Hyojun Sho is not optional. The good news is that if a device manufacturer has previously…

…What device manufacturers need to do As stated in the previous section, the Seihin Hyojun Sho is not optional. The good news is that if a device manufacturer has previously…

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Team software process for medical devices

Developing High Quality Medical Device Software Leveraging The Team Software Process

By Carl Wyrwa

…Projects in the Top Companies, McGraw-Hill. National Medal of Technology Winner Watts Humphrey (2010). 1927-2010 (Software Engineering Institute, Carnegie Mellon University, University News Items, October 28, 2010). Humphrey, W.S., Chick,…

…Projects in the Top Companies, McGraw-Hill. National Medal of Technology Winner Watts Humphrey (2010). 1927-2010 (Software Engineering Institute, Carnegie Mellon University, University News Items, October 28, 2010). Humphrey, W.S., Chick,…

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