Design Planning, Design History Files and Design Reviews

Description

Design planning, use and maintenance of design history files and periodic design reviews are crucial and integral parts of design control.  All development projects in the medical device space will start with design planning. Without robust planning, it is not possible to keep track of everything that is needed during the development of a medical device. The planning stage and process will lay out and define the tasks needed to complete the development process as well as define subordinate plans to keep track of related activities such as regulatory or production plans.  Proper use and application of the design history file is not only required but essential in documenting the development process. All records related to the development of a product are stored in the design history file and as such, it must be organized, accessible, searchable and secure.   Finally, design reviews are key to track the progress…