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

Annex IV (EC Declaration of Conformity – Full Quality Assurance System)

By Dr. Christopher Joseph Devine

…of the Directive, issue the application with an EC design-examination certificate. The notified body may require the application to be completed by further tests or proof to allow assessment of…

…of the Directive, issue the application with an EC design-examination certificate. The notified body may require the application to be completed by further tests or proof to allow assessment of…

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Paul Leonard is Director of Programs for product development consultancy Carbon Design Group
MEDdesign

Sustainability in Medical Device Design—Material Considerations

By Paul Leonard

…radar: Plexiglas® Rnew from Altuglas International is a relatively new, sustainable, bio-based acrylic resin that incorporates high levels of carbon from renewable resources. BPA-free Rnew has great clarity, gamma sterilization…

…radar: Plexiglas® Rnew from Altuglas International is a relatively new, sustainable, bio-based acrylic resin that incorporates high levels of carbon from renewable resources. BPA-free Rnew has great clarity, gamma sterilization…

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

IVDD Annex III Declaration of Conformity

By Dr. Christopher Joseph Devine

…be completed by further tests or proof to allow assessment of conformity with the design-related requirements of the Directive. The certificate shall contain the conclusions of the examination, the conditions…

…be completed by further tests or proof to allow assessment of conformity with the design-related requirements of the Directive. The certificate shall contain the conclusions of the examination, the conditions…

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

IVDD Annex II

By Dr. Christopher Joseph Devine

…the path for establishing and complying with essential requirements; and hopefully, the eventual approval from your notified body. For example, if a device falls under List A (high-risk devices), Dr….

…the path for establishing and complying with essential requirements; and hopefully, the eventual approval from your notified body. For example, if a device falls under List A (high-risk devices), Dr….

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Chris Loughnane, is an engineer at Farm
MEDdesign

Building Adaptable CAD Databases—How and Why

By Chris Loughnane

…explicit relationship, information typically makes its way into the CAD database via a more circuitous path: Data is obtained CAD is adjusted to reflect new data Design is prototyped Prototype…

…explicit relationship, information typically makes its way into the CAD database via a more circuitous path: Data is obtained CAD is adjusted to reflect new data Design is prototyped Prototype…

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

IVDD Article 22 – Implementation, Transitional Provisions

By Dr. Christopher Joseph Devine

  Article 22 (Implementation, Transitional Provisions) of the IVDD (98/79/EC) delineates the salient requirement that Member States must comply with this Directive. Compliance to Directives is not optional for the…

  Article 22 (Implementation, Transitional Provisions) of the IVDD (98/79/EC) delineates the salient requirement that Member States must comply with this Directive. Compliance to Directives is not optional for the…

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

IVDD Article 21 – Amendment of Directives

By Dr. Christopher Joseph Devine

…(2011, December). Commission decision amending decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices. Retrieved March 2, 2012, from http://eur-lex.europa.eu. Commission Directive 2011/100/EU. (2011, December). Commission directive…

…(2011, December). Commission decision amending decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices. Retrieved March 2, 2012, from http://eur-lex.europa.eu. Commission Directive 2011/100/EU. (2011, December). Commission directive…

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

IVDD Article 19 – Confidentiality

By Dr. Christopher Joseph Devine

…notified bodies such as TUV-SUD America will insist on having a signed contract and NDA in place prior to commencing with a business relationship. As for the Competent Authorities, they…

…notified bodies such as TUV-SUD America will insist on having a signed contract and NDA in place prior to commencing with a business relationship. As for the Competent Authorities, they…

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

IVDD Article 18 – Decisions in Respect of Refusal or Restriction

By Dr. Christopher Joseph Devine

…movie) to the health of their general public. Regardless, Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the…

…movie) to the health of their general public. Regardless, Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the…

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Rob Lichty
MEDdesign

Biomimicry – The Glue That Binds Us

By Rob Lichty

…temperature and solid at body temperature and is twice as strong as the worm’s glue. The team envisions this product as a new means for putting compound/complex fractured bones back…

…temperature and solid at body temperature and is twice as strong as the worm’s glue. The team envisions this product as a new means for putting compound/complex fractured bones back…

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