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aja38 replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years, 11 months ago
I think the most effective would first be getting the customer’s needs to draw baseline from there look into competitors in the field with same background in order to create a better device. Looking into competitors will help improve or better the device input. Next, to me would be working with regulatory and quality control department. Regulatory will help make sure device follows FDA and other agency rules, if something is missing we can add to design input to regulate the device. Quality control will establish all risk, which the team can add or change design inputs to make medical device safe. The last process would be going to the customers whether being a corporation, surgeon, scientist, engineer, etc for final check because the customer will be buying the product, the device needs to meet customer desire, safety, and efficient.