As discussed in the last post, there is specific documentation that needs to be in place for the design process. This week we will cover the topic of design input, and in following weeks we will address the other required design procedures.
Design and development activities can be performed to create new products or to update devices already in production. Design inputs are the cornerstone of product design – they help define the initial requirements that triggered the development of the device. ISO 13485 identifies various types of design inputs. This includes, but is not limited to: functional and performance requirements, applicable regulatory requirements, customer requirements, feedback from previous products already produced by the company, process performance data, safety requirements, along with any other detail essential for development of the device. These inputs must be identified and formulated in a way that can be verified and validated as the device goes through the development process. Consideration must also be given to ensure that inputs are complete, unambiguous, and not conflicting with each other.