Quality professional in device start-up company

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Reference no: EM133374354

As the Quality Professional in a device start-up company, you are asked by the CEO to prepare proposed design control and development plan for a contact lenses Class II device.

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?

Design validation

How will you determine if you made the right product? will you do pilot testing?

Design reviews

Will you have them? how often? who will attend?

Design transfer

How will you transfer the design to production? will you have SOPs to do this? Will you pass along drawings? specs?

Design History File

Will you have one? What will be in it?

What title/job position would be involved in each step?

Reference no: EM133374354

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