Design Quality Assurance


This module will give students an understanding of the four phases of design and development from product concept to manufacturing with particular focus on understanding and ensuring market needs, user requirements and regulatory compliance.

Learning Outcomes

  1. Explain the four phases of Design and Development that meet standards/regulations including relevant ISO and FDA standards and regulations.

  2. Evaluate product design to ensure compliance with requirements such as essential safety and performance requirements of US and European directives and regulations

  3. Plan new product introduction including process design and product transfer operations

  4. Conduct product design reviews, verification and validation

  5. To have an understanding of key design input requirements including software, electrical safety, radiation, mechanical, usability and user interface criteria.

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