Module 14 2022

14/03/2022

Design and Development Planning

• Describes design and development activities

• Identify, describe and define interfaces, responsibilities and activities impacting device design. Key milestones. • Non-prescriptive • Flexible and evolve in parallel with the project

● Project Charter – Market Requirements, User Needs ● Project Time Plans – Timelines, milestones, charts ● Stage Initiation Forms – Stage-level plan, risk approach.

User Need “New drug ‘X’ needs to be delivered via autoinjector”

The Organisation for Professionals in Regulatory Affairs

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Design Input 21 CFR 820.30( c )

(c) Each manufacturer shall …. ensure that the design requirements …. address the intended use of the device, including the needs of the user and patient…..The design input requirements shall be documented and…. reviewed and approved ….The approval , including the date and signature ….shall be documented .

The Organisation for Professionals in Regulatory Affairs

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