How will you determine if you made the product correctly

Reference no: EM133384418

As the Quality Professional in a device start-up company, you are asked by the CEO to proposed design control and development plan for a new Catheter. (explain in detail following with adequate references)

Design Planning

Cover the goal, objectives, scope, tasks, deliverables, estimated time frame of the project , resources, responsibilities etc.

Design Inputs

Any applicable standards? regulatory requirements (510 k. PMA?), characteristics of the device, safety standards (if any) labeling (user manual?)etc

Design Verification

How will you determine if you made the product correctly?

Reference no: EM133384418

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