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By Jim Kasic, Boulder iQ | Medical device assembly and packaging are often afterthoughts, but they are critical decisions. Consider these crucial factors to make the right decision for your device and your company. |
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By Maggie Chan, Ramsay Black, and Emanuel Wasson, PA Consulting | There is increasing pressure on manufacturers to make devices that combine safety and effectiveness with sustainability, particularly with regard to EU regulations and directives. |
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By Jayet Moon and Arun Mathew | The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process. |
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