In the quality system assessment of medical device manufacturers in the design control of the specific are required to provide what materials?

Hello, the system information is needed. You can refer to 0287 or 13485 on the design control program to do.

1, design and development planning

2, organizational and technical interfaces

3, design inputs

4, design outputs

5, design review

6, design validation

7, design verification

8, change control of design and development

There are some forms involved. Forms are: (design and development mission statement, information contact processing sheet, design and development input records, design and development output list, quality inspection records, document change notification form, clinical trial report, clinical trial program, design and development review records, design and development verification records, design and development confirmation records, project proposal, etc.)

You follow the program inside the requirements to prepare the details of the things, you will also be clear. You'll be clear on that.