What is design control in quality

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Design and development for medical devices must record and implement all essential performance and product requirements in order to ultimately meet the needs of end customers. Manufacturers face the challenge of finding suitable technical solutions, ensuring product safety and implementing risk controls for potential product defects, while at the same time having to comply with all relevant regulations.

ISO 13485: 2016 helps in the effective and controlled implementation of design activities for medical devices. It's an ideal blueprint for making sure the jump from design to development is done in a structured way. With its new requirements for design and development, it has not only made the process more secure for the executing organizations, but now also adapts perfectly to the requirements of the FDA for design control.

Technically, "design control" is an FDA term and is defined in the FDA requirements for quality systems for the development of medical devices (QSR) 21 CFR 820.30. It's basically a system of checks and balances to make systematic design reviews an integral part of development. In ISO 13485: 2016, the terminology and purpose are similar. Section 7.3 Design and Development contains all essential elements of design control as requirements for product realization.

Your advantage

  • You will gain valuable insights into the most important steps in a design development process that meets both ISO 13485: 2016 and the FDA's QSR requirements.
  • You will understand the purpose and intent of design controls, how they can be meaningfully used, and how they support medical device development.
  • You will be guided step by step through the design and development process using practical examples.
  • You will receive best practice tips from the industry on how you can efficiently create design and development documents along the process.

content

  • Design and development process: Lean but helpful. Key elements for steering all important development activities.
  • Design and development planning: As much as necessary, as little as possible with an emphasis on controlling the design and enough leeway for development.
  • Input for design and development: "As ordered, delivered". Roadmap to make the development inputs complete, clear and consistent as well as verifiable or validatable.
  • Design and development results: The design solutions are taking shape. How to translate design and development inputs into a specific medical device.
  • Evaluation of design and development: trust is good, control is better. How to turn it into a useful event for everyone involved.
  • Verification and Validation of Design and Development: The culmination of all development efforts and the moment of truth. How to prove that the right medical device was designed the right way.
  • Transfer of design and development: Just before the finish line. How to make sure everything needed to make it is there.
  • Control of design and development changes: Changes are an opportunity for improvement. How to manage necessary changes without starting from scratch.
  • Design and development documentation: The development file contains objective evidence that the developed medical device is safe and effective for its intended purpose. How it turns into a really good story.