VOC allows one to determine important aspects that govern product development. Of these customer needs are possibly the most critical as they define your product requirements. Importantly at this stage the relative product regulatory requirements need to be fed into the process. Once set, a prototype can be developed. This PROTOTYPE allows the subsequent stages of stability to be started. 

Most importantly one can enter the critical phases of verification and validation. Failure at this stage can lead to extended time lines and escalating costs depending on when the error is identified. The worst case is to launch with a product that the customer can’t use or worse still won’t use.

Based on our experiences of developing a wide range of IVD products, including CE/IVD, Class I, Class II (510k) and Class II (PMA) we can mitigate these issues. We can advise and reflect on the process to be employed for the better development of your products.