What are Design Controls?

Design Controls Definition

Design controls are a set of quality practices and procedures that are incorporated into the product design and development process to ensure that a device is appropriate for its intended use. Essentially, design control consists of planning, design execution, testing against specifications (inputs) and requirements (user needs), and uncovering and fixing problems at an early stage (risk reduction).

What are Design Controls


What are the elements of design control?

The key elements of design control are:

  1. User needs: Outlines the intended use and indications for use of the device
  2. Design inputs: Quantifiable design features that are intended to capture functional, safety, and performance requirements for the device
  3. Design outputs: Documents which serve as guidance for the production and assembly of the final product. They include drawings, design specifications, manufacturing instructions, component specifications, and assembly instructions
  4. Design verification and validation: Design verification ensures that the design output can consistently meet the design output. Design validation ensures that the final product can consistently meet user needs
  5. Design reviews: Each stage of the design process is reviewed to ensure that the device is safe and that design control parameters are properly implemented

*Source: https://www.proximacro.com

What are design control documents?

Design control documents include product design and development plans, drawings, design specifications, manufacturing instructions, component specifications, and assembly instructions.

*Source: https://www.proximacro.com

What are design controls under the FDA?

Design Controls, which are a systematic technique for developing Class II and Class III medical devices, are required by the FDA. This approach necessitates multiple layers of paperwork to show the FDA how you ensured the safety and efficacy of your medical device.

*Source: https://www.mindflowdesign.com

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