We can manage your product development project from concept to launch or piece us in as needed. If you’re starting a new project our talented team of engineers will help you translate your product idea into specific user needs and design input requirements that can be verified and validated in compliance with FDA and international regulatory requirements. Next, we generate concepts and prototypes for user feedback. Once your final concept is chosen we take it through our rigorous ISO 13485 development process by ensuring design controls, risk management, and configuration controls are implemented properly. If needed, we can manage your verification and validation strategy and finally your regulatory submission to ensure your product meets its regulatory requirements, intended use, and commercialization goals.
End to End Product Development
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