Devine Guidance

FDA versus the Notified Body

By Dr. Christopher Joseph Devine

Competent Authorities, from impacted Member States, will get involved. Note: the Competent Authorities are starting to bare their teeth and show some fangs. So many more comparisons are possible but…

Competent Authorities, from impacted Member States, will get involved. Note: the Competent Authorities are starting to bare their teeth and show some fangs. So many more comparisons are possible but…

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Ask the Engineer

Ask The Engineer: Sticky Questions on Adhesives

…the transmission through the plastic, is to measure the intensity of light coming through the plastic from the light source. You can calculate a percentage loss of transmission through the…

…the transmission through the plastic, is to measure the intensity of light coming through the plastic from the light source. You can calculate a percentage loss of transmission through the…

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Devine Guidance

Accurate DHRs are Never Optional

By Dr. Christopher Joseph Devine

…recognize the importance of the DHR, try managing your organization’s complaint management system, performing a complaint investigation, filing an MDR, or even attempting to manage a RECALL (Dr. D’s favorite…

…recognize the importance of the DHR, try managing your organization’s complaint management system, performing a complaint investigation, filing an MDR, or even attempting to manage a RECALL (Dr. D’s favorite…

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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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Tom Weaver, President, Weaver Consulting
CAPA Corner

Model for a CAPA Root Cause Investigation

By Tom Weaver

…describing the problem in 8 dimensions using the IS / IS NOT Diagram, which immediately places boundaries on the investigation thereby providing focus and narrowing the search for the change….

…describing the problem in 8 dimensions using the IS / IS NOT Diagram, which immediately places boundaries on the investigation thereby providing focus and narrowing the search for the change….

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Jason Higgins, Electrical and Software Engineer, Carbon Design Group
MEDdesign

Approaches to Developing New Medical Technologies

By Jason Higgins

…technology is fully understood. Arguably, when developing a novel technology, the latter approach can have considerable advantages. Design for Commercialization: The excitement of commercializing a product, compounded by the desire…

…technology is fully understood. Arguably, when developing a novel technology, the latter approach can have considerable advantages. Design for Commercialization: The excitement of commercializing a product, compounded by the desire…

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Devine Guidance

SCAR – A Favorite Acronym

By Dr. Christopher Joseph Devine

The doctor would like start this week’s Devine Guidance with a couple of questions. Can the readers point to Dr. D where the use of a Supplier Corrective Action Report…

The doctor would like start this week’s Devine Guidance with a couple of questions. Can the readers point to Dr. D where the use of a Supplier Corrective Action Report…

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Devine Guidance

Complying with 21 CFR, Part 807 for Establishment Registration

By Dr. Christopher Joseph Devine

…Website. Retrieved April 20, 2013, from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.  Medical device establishment registration and listing – notice of changes for FY 2013. (2012, August). FDA Website. Retrieved April 20, 2013, from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm. …

…Website. Retrieved April 20, 2013, from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.  Medical device establishment registration and listing – notice of changes for FY 2013. (2012, August). FDA Website. Retrieved April 20, 2013, from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm. …

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Devine Guidance

Regardless of QMS Structure, Internal Audits are Mandatory

By Dr. Christopher Joseph Devine

…13485:2012). Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf

…13485:2012). Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf

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James Rudolph, Senior Industrial Designer, Farm Design, Inc.
MEDdesign

Improving the Reliability of Usability Evaluations

By James Rudolph

comprehensive comparison of usability studies to date, involving 17 usability teams in total, nine of which performed expert reviews and eight of which conducted usability tests (Molich & Dumas, 2008)….

comprehensive comparison of usability studies to date, involving 17 usability teams in total, nine of which performed expert reviews and eight of which conducted usability tests (Molich & Dumas, 2008)….

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