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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Devine Guidance

MHLW MO 169 – Chapter 3 – Documents Concerned with Manufacturing and Quality Control

By Dr. Christopher Joseph Devine

…Japanese, the phrase is: “覆水盆に帰らず.” The literal translation is “Spilled water will not return to the tray” or simply stated, “No use crying over spilled milk.” The good news is…

…Japanese, the phrase is: “覆水盆に帰らず.” The literal translation is “Spilled water will not return to the tray” or simply stated, “No use crying over spilled milk.” The good news is…

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

MHLW MO 169 – Chapter 2/Section 6 – Improvement

By Dr. Christopher Joseph Devine

…PMDA, it is probably part of a longer conversation about removing medical devices from the Japanese market that fail to meet safety and efficacy standards. The good news is, the…

…PMDA, it is probably part of a longer conversation about removing medical devices from the Japanese market that fail to meet safety and efficacy standards. The good news is, the…

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

MHLW MO 169 – Chapter 2/Section 6 – Internal Audit

By Dr. Christopher Joseph Devine

…manufacturers. The good news is hiring Second Party Auditors (a.k.a. consultants like Dr. D) is an acceptable practice. The key is to ensure the Second Party Auditor is competent. Another…

…manufacturers. The good news is hiring Second Party Auditors (a.k.a. consultants like Dr. D) is an acceptable practice. The key is to ensure the Second Party Auditor is competent. Another…

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Jim Webb is a Program Director for Carbon Design Group

Sustainability in Medical Devices – Disposables

…references: Many Hospitals Now Safely Reuse ‘Single-Use’ Medical Devices, by Kathryn Siranosian. Triple Pundit.com. March 12th, 2010 Sustainability Issues Looming for Designers, by Frank Esposito. Plastic News. April 25, 2011…

…references: Many Hospitals Now Safely Reuse ‘Single-Use’ Medical Devices, by Kathryn Siranosian. Triple Pundit.com. March 12th, 2010 Sustainability Issues Looming for Designers, by Frank Esposito. Plastic News. April 25, 2011…

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

MHLW MO 169 – Chapter 2/Section 5 – Purchasing

By Dr. Christopher Joseph Devine

…on-site assessment is probably going to be in order due to the significant increase in risk associated with finished medical device sterilization. The good news is that the purchasing process…

…on-site assessment is probably going to be in order due to the significant increase in risk associated with finished medical device sterilization. The good news is that the purchasing process…

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