Design Trace Matrix Ensuring that Design Outputs meet Design Inputs wanted

[SK Vision]

Does anyone have a good example of a Design Trace Matrix that would provide a template for ensuring that Design Outputs meet Design Inputs?

Many thanks,

SK

[Marc]

You might want to 'Bump' this thread next Monday or Tuesday morning when more people are around. This is kinda a niche area. I wish I could help, but I have nothing to offer and medical devices is out of my field.

[Chris Ford]

Originally Posted by SK Vision

Does anyone have a good example of a Design Trace Matrix that would provide a template for ensuring that Design Outputs meet Design Inputs?

Many thanks,

SK

Here's a sample traceability matrix. Every project is different, though. It depends on where you documents requirements, specifications and the verification.

Essentially, you need to list out the top level requirements, then show where those requirements are translated into specifications. I include the risk management requirements, then show how those specs are all verified. The next columns would include the validation results.

I hope this helps.
Chris Ford

[Marc]

Thanks, Chris!

[SK Vision]

CHRIS,

REALLY appreciate the help. This is awesome.

SK