When developing medical devices many challenges must be overcome but Design Control does not have to be one of them.

Design control is a set of quality practices and procedures incorporated into the design and development process to control the design process and assure that device specifications meet user needs and intended use.



A good project start with a plan

A good project starts with a plan (1) describing the scope for the project. Then the first step in defining your Design Input is to identify the users’ needs (2a) These are then broken down into technical requirements (2b Design Input). The Design Process (3) is where the medical device is designed, and this process results in Design Output (4) such as specifications describing the medical device design. Formal Design Reviews (5) are performed where appropriate. When the medical device is designed it must undergo Design Verification (6) to ensure that the Design Output meets the Design Input. When the Medical Device (7) have undergone successful Design Verification, the Design Validation (8) is initiated to ensure that the final design meets the User Needs and Intended Use. Design transfer (8) ensures that the device design is correctly translated into production specifications. Design changes (9) must be assessed for impact and managed before implementation. Records of the design control process are contained or referenced in the Design History File (10).


Our article will also walk you through the following subjects


   Design Planning    Design Input
   Design Process    Design Output
   Design Review    Design Verification
   Design Validation    Design Transfer
   Design Changes    Design History File



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