Module 14 2022
14/03/2022
Effective Planning
• Knowledge/Design Space Management
• Defined Inputs/Outputs per stage
• Traceability
The Organisation for Professionals in Regulatory Affairs
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Learning Outcomes
• The key distinctions between different types of design control, and their importance in delivering safe and effective medical devices.
• Understanding how design control can be used effectively whilst promoting the growth of knowledge and design space.
• The role of effective design planning in ensuring appropriate inputs are developed.
• How design inputs are translated into design outputs through an iterative design process.
The Organisation for Professionals in Regulatory Affairs
28
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