Bob is a Farm senior mechanical engineer.

MEDdesign: Utilizing Data to Influence Tomorrow’s Design

…The development tools in our high-tech toolbox are always expanding and bringing new insight to increasingly complex systems. But without a detailed product specification roadmap, we fall into the trap…

…The development tools in our high-tech toolbox are always expanding and bringing new insight to increasingly complex systems. But without a detailed product specification roadmap, we fall into the trap…

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Ask the Engineer

Adhering Polyethylene to Various Substrates

By Irene Boutin

…Product data sheets are available at www.dymax.com. One simple but effective method to monitor if the curing has gone to completion is incorporated into the 1201-M-SC product. This material uses…

…Product data sheets are available at www.dymax.com. One simple but effective method to monitor if the curing has gone to completion is incorporated into the 1201-M-SC product. This material uses…

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

Introduction to the Japanese Medical Device Market

By Dr. Christopher Joseph Devine

…in Japan. (2012). Emergo Group Website. Retrieved June 10, 2012, from http://www.slideshare.net/emergogroup Will you let slip the world 2nd largest medical device market? (2010). Retrieved June 8, 2012, from http://www.asiaitc.com/download

…in Japan. (2012). Emergo Group Website. Retrieved June 10, 2012, from http://www.slideshare.net/emergogroup Will you let slip the world 2nd largest medical device market? (2010). Retrieved June 8, 2012, from http://www.asiaitc.com/download

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

IVDD Epilogue

By Dr. Christopher Joseph Devine

…mantra, “Just Comply, Baby!” Dr. D really struggled on how to wrap-up and place a pretty bow on this series about understanding and complying with the IVDD. Since it really…

…mantra, “Just Comply, Baby!” Dr. D really struggled on how to wrap-up and place a pretty bow on this series about understanding and complying with the IVDD. Since it really…

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Rob Lichty
MEDdesign

Biomimicry – How Far Do You Take It?

By Rob Lichty

…Much research has been done to figure how this is possible. Examples include Kobe University, Osaka University, and Tezpur University. A modern commercially available product of this genre is available…

…Much research has been done to figure how this is possible. Examples include Kobe University, Osaka University, and Tezpur University. A modern commercially available product of this genre is available…

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

IVDD Annex X (CE Marking of Conformity)

By Dr. Christopher Joseph Devine

…mission critical. The notified bodies will assess a device manufacturer’s QMS and issue a certificate stating compliance, if the QMS is deemed in compliance with the EN ISO 13485:2003 and…

…mission critical. The notified bodies will assess a device manufacturer’s QMS and issue a certificate stating compliance, if the QMS is deemed in compliance with the EN ISO 13485:2003 and…

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Devine Guidance

IVDD Annex IX

By Dr. Christopher Joseph Devine

comes to complying with the IVDD or the other device Directives, Dr. D has an elementary phrase for you. “No CE marking of conformity equates to no revenue stream coming…

comes to complying with the IVDD or the other device Directives, Dr. D has an elementary phrase for you. “No CE marking of conformity equates to no revenue stream coming…

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Carl Dumas, Software Engineering Manager, Ximedica
Ask the Engineer

Conducting Software Validation

By Carl Dumas

…as a continuously woven thread through all phases of project development, then and only then will you gain full confidence in the overall system in addition to complete regulatory compliance….

…as a continuously woven thread through all phases of project development, then and only then will you gain full confidence in the overall system in addition to complete regulatory compliance….

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Terri Marion, Silicone Business Development Manager, GW Silicones, Inc.
Ask the Engineer

LSR Use in Devices

By Terri Marion

…the Engineer addresses some questions on uses of LSR in medical devices, how it can be injection molded, and 2K molding (multi-component LSR molding). Q: Several of my customers have…

…the Engineer addresses some questions on uses of LSR in medical devices, how it can be injection molded, and 2K molding (multi-component LSR molding). Q: Several of my customers have…

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

IVDD Annex V (EC Type – Examination)

By Dr. Christopher Joseph Devine

Annex V (EC Type-Examination) is all about examination. Who knew? Seriously, notified bodies are required to examine and certify that samples provided as representative of the device manufacturer’s manufacturing process…

Annex V (EC Type-Examination) is all about examination. Who knew? Seriously, notified bodies are required to examine and certify that samples provided as representative of the device manufacturer’s manufacturing process…

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