Every medical device starts with an idea. Then this idea has to be transformed into a product that is safe and efficient. Easier said than done. To keep the overview, Design Control provides some useful tools. Requirements will be defined and foreseeable risks identified. Subsequently, it is verified whether the product meets the defined requirements and whether the benefits expected by the user and patient are achieved (validation). The process is concluded with the design transfer, i.e. the transfer of the development results to production, and manufacturing can begin.
Each step of the development process must be documented. Whether a manufacturer chooses one of the common models for this (waterfall model or V-model) or not - it is important that the basic sequence of the individual steps in the development process is adhered to. To successfully complete a development process, you need both experience and an understanding of the dependencies and sequences in such a controlled process.
Currently, many companies are facing challenges in the development of software and AI applications. Especially when the verification of such products is still little practiced. Our experts can also support you in these projects and accompany you all the way to the finished product.
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