Medical Device Design Control Procedure Bundle

The medical device design control procedure bundle includes design control and related procedures addressing design control requirements of ISO 13485:2016 and FDA QSR. The design control procedure manages a phased approach to product design. The design review procedure documents a technical discussion of design phases. The design transfer procedure guides the transfer of products and processes from development to manufacturing. The design verification and validation procedure provide instruction on how to conduct design verification and validations. The procedures include forms and checklists to guide staff through these processes and are in MS Word format. The medical device design control procedure bundle captures the core requirements of design control processes.