Chris Loughnane, is an engineer at Farm
MEDdesign

Building Adaptable CAD Databases—How and Why

By Chris Loughnane

…(but not less) 10 simple features > 1 complex feature and so on… While these will take you a long way, adaptable databases, as mentioned before, go further. Adaptable databases…

…(but not less) 10 simple features > 1 complex feature and so on… While these will take you a long way, adaptable databases, as mentioned before, go further. Adaptable databases…

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

Product Development Process Safeguards

By David A. White

…have features added to anchor it to a pallet or isolate it from shocks in transport. Address marketing challenges. Hopefully the marketing team was intimate with the evolution of the…

…have features added to anchor it to a pallet or isolate it from shocks in transport. Address marketing challenges. Hopefully the marketing team was intimate with the evolution of the…

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

MDD – Annex X

By Dr. Christopher Joseph Devine

…conditions the device will typically be employed. c. Device features and performance characteristics must be appropriately examined for safety and efficacy while considering the overall impact to the patient, including…

…conditions the device will typically be employed. c. Device features and performance characteristics must be appropriately examined for safety and efficacy while considering the overall impact to the patient, including…

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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

…phase of development. CAD is hard to change. No one says that out loud because CAD is sold to the market as “easy to change.” The parametric software features in…

…phase of development. CAD is hard to change. No one says that out loud because CAD is sold to the market as “easy to change.” The parametric software features in…

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

MDD – Definitions and Scope

By Dr. Christopher Joseph Devine

…shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned. 4. Where…

…shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned. 4. Where…

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

Acceptance Activities

By Dr. Christopher Joseph Devine

…specification creators glom the opportunity and work with the suppliers in determining critical features requiring monitoring and measurement data, in support of a Supplier Statistical Data Program (SSDP). Your suppliers…

…specification creators glom the opportunity and work with the suppliers in determining critical features requiring monitoring and measurement data, in support of a Supplier Statistical Data Program (SSDP). Your suppliers…

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Building the Clinical Risk Perspective into Medical Device Manufacturing

By Thomas Maeder

…manufacture, with new features or broader applications—may inadvertently introduce clinical risk factors invisible to engineers. “The sophistication of how we assess risk has evolved, both at the Agency and in…

…manufacture, with new features or broader applications—may inadvertently introduce clinical risk factors invisible to engineers. “The sophistication of how we assess risk has evolved, both at the Agency and in…

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

Design Verification and Design Validation

By Dr. Christopher Joseph Devine

…all of the features of the device design. One additional and extremely important requirement is the conditions under which design validations should be executed. For starters, design validation testing needs…

…all of the features of the device design. One additional and extremely important requirement is the conditions under which design validations should be executed. For starters, design validation testing needs…

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