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

IVDD – An Introduction

By Dr. Christopher Joseph Devine

comply-baby-comply!” Regardless of the perceived idiosyncrasies associated with 98/79/EC, compliance to this Directive is mandated by law within the EU. The similarities to 93/42/EEC should make compliance to the IVDD…

comply-baby-comply!” Regardless of the perceived idiosyncrasies associated with 98/79/EC, compliance to this Directive is mandated by law within the EU. The similarities to 93/42/EEC should make compliance to the IVDD…

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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 II

By Dr. Christopher Joseph Devine

…For device manufacturers not achieving compliance with the EN ISO 13485:2003, compliance with Annex II is going to be problematic. In fact, you might as well commence looking for another…

…For device manufacturers not achieving compliance with the EN ISO 13485:2003, compliance with Annex II is going to be problematic. In fact, you might as well commence looking for another…

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

MDD – Annex I

By Dr. Christopher Joseph Devine

commence this series of articles with the review and guidance for complying with Annex I of the MDD, “Essential Requirements.” Full text of MDD – 93/42/EEC ANNEX I – Essential…

commence this series of articles with the review and guidance for complying with Annex I of the MDD, “Essential Requirements.” Full text of MDD – 93/42/EEC ANNEX I – Essential…

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

MDD – Article 20a

By Dr. Christopher Joseph Devine

…a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm  …

…a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm  …

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

MDD – Article 19

By Dr. Christopher Joseph Devine

…are “safe, effective, and compliant” with their essential requirements, while being properly certified by their notified body!” An easy way to remember the three-key elements of the doctor’s secret is…

…are “safe, effective, and compliant” with their essential requirements, while being properly certified by their notified body!” An easy way to remember the three-key elements of the doctor’s secret is…

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

MDD – Article 14a

By Dr. Christopher Joseph Devine

…the second date, the evaluation of the databank by the Commission. From Dr. D’s perspective, I guess the Commission felt compelled to ensure the databank was fully operational before 12/21/12,…

…the second date, the evaluation of the databank by the Commission. From Dr. D’s perspective, I guess the Commission felt compelled to ensure the databank was fully operational before 12/21/12,…

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

MDD – Article 14

By Dr. Christopher Joseph Devine

…Moving on, as Dr. D continues to concatenate (look-it up if you must), articles on the MDD, the underlying theme of the series continues to be compliance, compliance, and more…

…Moving on, as Dr. D continues to concatenate (look-it up if you must), articles on the MDD, the underlying theme of the series continues to be compliance, compliance, and more…

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

MDD–Article 12a

By Dr. Christopher Joseph Devine

…the Community. In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate…

…the Community. In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate…

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