RegionWhat is Design Control?
Design Control is a systematic approach to the development and production of products, particularly medical devices. It involves a formal methodology that ensures the product meets user needs and company-defined specifications.
What are the key elements of design control?
- Design and Development Planning: Planning the development process, including assigning responsibilities and interfaces.
- Design Input: Identifying the intended use, user needs, and other design requirements.
- Design Output: Developing the design outputs that meet the design input requirements.
- Design Verification: Confirming that the design outputs meet the design input requirements.
- Design Validation: Ensuring that the design meets the predetermined user needs and intended uses.
- Design Review: Conducting reviews of the design process to ensure it is on track.
- Design Transfer: Transferring the design to production specifications.
- Design Changes: Controlling changes to the design and ensuring they are validated or verified as necessary.
- Design History File: Maintaining a record of the design process to demonstrate compliance with regulations.
What is design validation in design control?
Design validation is a critical component of design control for medical devices. It establishes by objective evidence that the device specifications conform to user needs and intended uses. Design validation is performed under defined operating conditions on initial production units or their equivalents and under actual or simulated use conditions. Design validation aims to prove that the correct product has been developed to meet user requirements. Design validation is distinct from design verification, which confirms that the design outputs meet the design inputs, and that the product has been developed correctly.
