A design control procedure is used to ensure that the specified design requirements for each product are fully met. The processes for medical device development differ slightly from those for foods and cosmetics due to the regulatory requirements for each product sector.
Procedures for each are detailed below.
As an example of Medical Devices, the procedure can be broken down into the following areas:
- Design Planning - Establishes a broad plan that details the design and development activities and defines the project team and responsibilities for implementation.
- Design Input - Defines the performance characteristics of the product and considers external factors such as the environment and energy requirements. Regulatory demands and human factors, such as ease of use, will also be considered.
- Design Output - Evaluation of the product against specific acceptance criteria which ensure the product functions properly and conforms to the specific regulatory requirements.
- Design Review - Formal documented reviews conducted at appropriate intervals during the development cycle that include representatives of all functions concerned with the design. The review procedure ensures that the design requirements are adequate, the design meets the necessary requirements and that any problems are identified.
- Design Verification - Ensures that the product the design team develops is what they intended to be developed. This process assures all safety performance and reliability requirements have been met, including product usage under simulated use conditions.
- Design Validation - Performed prior to release, this process confirms the product the design team has developed is what the customer wants and needs - ie. the design outputs meet the design inputs.
- Design Transfer - Translates the product design into production specifications, methods and procedures. Process validations will also be performed where appropriate as part of this exercise.
- Design History File - A detailed record that demonstrates that the design was developed in accordance with the approved design plan.