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

IVDD – An Introduction

By Dr. Christopher Joseph Devine

…http://www.sgs.com/ivd-medical-devices-white-paper   Dr. D’s first book “Devine Guidance for Complying with the FDA’s Quality System Regulation” has finally been published. Visit http://devineguidanceinternational.com or Amazon to obtain a copy. (ISBN: 9781466358768)…

…http://www.sgs.com/ivd-medical-devices-white-paper   Dr. D’s first book “Devine Guidance for Complying with the FDA’s Quality System Regulation” has finally been published. Visit http://devineguidanceinternational.com or Amazon to obtain a copy. (ISBN: 9781466358768)…

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

MDD – Annex XII

By Dr. Christopher Joseph Devine

…Until the next installment of DG, when Dr. D commences with the launching of a new series, Devine Guidance for Complying with Directive 98/79/EC, the In Vitro Diagnostic Medical Device…

…Until the next installment of DG, when Dr. D commences with the launching of a new series, Devine Guidance for Complying with Directive 98/79/EC, the In Vitro Diagnostic Medical Device…

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

MDD – Annex XI

By Dr. Christopher Joseph Devine

…out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures…

…out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures…

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

MDD – Annex X

By Dr. Christopher Joseph Devine

…of clinical research and data. Depending on the device classification and intended device use, the clinical evaluation can be premised on the search and subsequent analysis of clinical data for

…of clinical research and data. Depending on the device classification and intended device use, the clinical evaluation can be premised on the search and subsequent analysis of clinical data for

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David A. White is the President/CEO of DesignDesign Inc.,
MEDdesign

Which Comes First, the Chicken or the Egg?

By David A. White

…development speeds up and consensus can come sooner. Pictures are great, but no doubt, models trump pictures. I knew another engineering fellow in DuPont named George, a scrimshaw artist. He…

…development speeds up and consensus can come sooner. Pictures are great, but no doubt, models trump pictures. I knew another engineering fellow in DuPont named George, a scrimshaw artist. He…

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Aidan Petrie, Chief Innovation Officer and Co-Founder, Ximedica
MEDdesign

Integrating HFID Throughout Development

By Aidan Petrie

…remain intact. However, next comes the challenge of managing the many other activities for success and regulatory approval. I have long argued that in development programs, particularly long and complex…

…remain intact. However, next comes the challenge of managing the many other activities for success and regulatory approval. I have long argued that in development programs, particularly long and complex…

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Rob Lichty
MEDdesign

Biomimicry – Design Inspired by Nature

By Rob Lichty

…taste, I suggest you peruse the www.asknature.org website. Biomimcry is a multidisciplinary hard science that takes advantage of millions of organisms and nearly four billion years of real life Research

…taste, I suggest you peruse the www.asknature.org website. Biomimcry is a multidisciplinary hard science that takes advantage of millions of organisms and nearly four billion years of real life Research

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

MDD – Annex V

By Dr. Christopher Joseph Devine

…to law within the EU, and device manufacturers are required to comply with the MDD. Dr. D would like to reiterate DG Rule # 1 – Compliance to regulations is…

…to law within the EU, and device manufacturers are required to comply with the MDD. Dr. D would like to reiterate DG Rule # 1 – Compliance to regulations is…

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

MDD – Annex IV

By Dr. Christopher Joseph Devine

for his ongoing reference to it – but it is the doctor’s blog) when it comes to the completeness of technical files; the additional oversight by notified bodies is a…

for his ongoing reference to it – but it is the doctor’s blog) when it comes to the completeness of technical files; the additional oversight by notified bodies is a…

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