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?