…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…
…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…
…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…
…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…
…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…
…The next step is to add a flat to the shaft and I want to make sure the analysis is set up correctly before including features that cannot be checked…
…The next step is to add a flat to the shaft and I want to make sure the analysis is set up correctly before including features that cannot be checked…
…requirements. Gage R & R Once the features required for measurement have been identified, the execution of a Gage R & R study becomes the foundation for determining accuracy of…
…requirements. Gage R & R Once the features required for measurement have been identified, the execution of a Gage R & R study becomes the foundation for determining accuracy of…
…the supplier to take the lead in identifying the appropriate characteristics requiring ongoing measurement and monitoring for statistical analysis. There are four categories of features requiring measurement: Critical (C), major…
…the supplier to take the lead in identifying the appropriate characteristics requiring ongoing measurement and monitoring for statistical analysis. There are four categories of features requiring measurement: Critical (C), major…
…the development phase. Another feature, found on a well-defined specification, is the identification of key features that can be measured by a supplier, and the statistical data provided for review,…
…the development phase. Another feature, found on a well-defined specification, is the identification of key features that can be measured by a supplier, and the statistical data provided for review,…
