J
Jennifer27
Hi all!
I'm preparing a Design Control document for 510k of a Class II software with moderate level of concern. I want to know
What all things will go in the design control for 510k submission
As per my understanding I should put in:
1. Design and Development Plan
2. Design Description (Including Design Input, change, control, transfer and output)
3. As summary of the source code and my entire source code
4. Traceability analysis and related documents
Please let me know if I should add or delete anything.
Also do we need to submit our Device Master Record and Design History File to the FDA?
I look forward to your input
Thanks so much
Jennifer
I'm preparing a Design Control document for 510k of a Class II software with moderate level of concern. I want to know
What all things will go in the design control for 510k submission
As per my understanding I should put in:
1. Design and Development Plan
2. Design Description (Including Design Input, change, control, transfer and output)
3. As summary of the source code and my entire source code
4. Traceability analysis and related documents
Please let me know if I should add or delete anything.
Also do we need to submit our Device Master Record and Design History File to the FDA?
I look forward to your input
Thanks so much
Jennifer
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