Design Control and Risk Management


Through this module, the student will understand and apply Design Control and Risk Management principles to the design of Medical Devices.

The module content includes the full Design and Development process including the full product life cycle from product concept to product launch, encompassing the phases of Design and Development and the elements of Design Control as required to ensure regulatory compliance. This module will also give the students an understanding of Risk Management as it applies to the design and development process and to medical device design. The content will be delivered such that it addresses the practical needs of industry, and all company sizes within the sector from Start-up through to SME's and multi-national corporations.

Learning Outcomes

  1. Critically evaluate product design to ensure compliance with essential safety and performance requirements. 

  2. Explain the technical documentation required to demonstrate compliance to relevant regulatory requirements and quality standards.

  3. Communicate and proceduralize the relationship between Design Control and Risk Management principles. 

  4. Demonstrate the ability to identify, critically assess, and manage risk throughout the medical device life cycle. 

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