SMART quality & compliance
What is the development lifecycle of a Medical Device?
What is the development lifecycle of a Medical Device? First and foremost, the user requirements need to be defined by the organization. Based on the fact that the design and development of the Medical Device can be planned, inputs are implemented and tested, which lead to outputs. The design and development process is then verified, and if needed, some inputs can be added (related to the outputs). The whole process is validated; the CE marking must be accepted before transferring the design and development to production and commercialization. The entire lifecycle is continually controlled. Risk management must be included in…
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