Design Control Project Question & Answer Guide (With Explanation)

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Original Question

Design Control Project As the Quality Professional in a device start-up company, you are asked by Executive team to prepare a proposed design control and development plan for a new Class II device for them. Please prepare this plan as a word document or a ppt presentation and submit through the Turnitin link as a PDF file.. There is no incorrect way to do this assignment, please use a format or template that you are comfortable with or have used in the past. Use any US Class II device as a guide from the FDA website. Here are a few examples of what could be submitted: Introduction: What product have you chosen and from where/why? Intended use of the product Indication for use for the product Intended market. Additional content (optional layout to ease out some stress). Feel free to use your own structure as well. These sections are not mandatory 1) Concept & Feasibility- Nothing much to say here.. but how a device got to the point of Design and development. Any design reviews conducted. 2) User needs & other stakeholder needs (could include Regulatory needs). 3) Design Planning Cover the goal, objectives, scope, tasks, deliverables, estimated time frame of the project , resources, responsibilities etc. Think about the team who would support the project 4) Design Inputs Any applicable standards? regulatory requirements (510 k. PMA?), characteristics of the device, safety standards (if any) labeling (user manual?)etc. Any other inputs to consider? Pick 3-5 inputs at a min. 5) Design Outputs Define relevant Design outputs based on the Design input requirements. Pick 3-5 outputs at a min 6) Design Verification How will you determine if you made the product correctly? Define Verification of Outputs meeting input requirements. What type of tests or what standards? 7) Design validation How will you determine if you made the right product? will you do pilot testing? Simulated use testing? Usability studies? 8) Design reviews Will you have them? how often? who will attend? 9) Design transfer How will you transfer the design to production? will you have SOPs to do this? Will you pass along drawings? specs? 10) Risk management file Just add what time of risk management documents you would need to generate and when will you start working on them. 11) Design History File Will you have one? What will be in it? What title/job position would be involved in each step? I hope this helps with the assignment. It should not be a challenge or tough assignment, merely an overview of a design plan.

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