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

Finally, eMDRs

By Dr. Christopher Joseph Devine

…enter MDR data into the program. The good news is that program aligns with 21 CFR, Part 803 so the user should always be able to enter the required data;…

…enter MDR data into the program. The good news is that program aligns with 21 CFR, Part 803 so the user should always be able to enter the required data;…

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

Time for Reflection

By Dr. Christopher Joseph Devine

…with less. The good news is, consulting firms such as Devine Guidance International are doing quite well as device manufacturers rush to fill voids created by layoffs. Conversely, using consultants…

…with less. The good news is, consulting firms such as Devine Guidance International are doing quite well as device manufacturers rush to fill voids created by layoffs. Conversely, using consultants…

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

Ship the Finished Device to Where?

By Dr. Christopher Joseph Devine

…for any Chief Jailable Officer to oversee. Enjoy! Warning Letter The good news for device manufacturers is that violations of §820.160 are rare events, as with today’s ERP/MRP technology basic…

…for any Chief Jailable Officer to oversee. Enjoy! Warning Letter The good news for device manufacturers is that violations of §820.160 are rare events, as with today’s ERP/MRP technology basic…

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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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