Technical File, GHTF's STED and Recommended Content of 510(k) Comparison/Relationship

[temujin]

Hi,
Does anyone have a comparison chart for the european "Tecnical File", GHTF´s STED and the recommended content of a 510(k)?

regards
t.

 

[harry]

Re: Technical File, GHTF's STED and Recommended Content of 510(k) Comparison/Relation

As far as I know, we don't have a comparison chart here but there's a recent discussion which is quite closely related: Technical Documentation, DMR, ISO 13485 vs. FDA, STED

It's also found in the 'similar discussions thread' box below after the retitling by Marc.

 

[rickyrikardo]

Hi,
Does anyone have a comparison chart for the european "Tecnical File", GHTF´s STED and the recommended content of a 510(k)?

regards
t.

This checklist is pretty close to what you may be looking for. It is comprehensive and has many adjustments I have done for a complex system-based/therapy product families, i.e., combos. It was shared with me and I am sharing with you. I only ask that if you improve and expand on it to pass and share your gains and insights.
Sincerely,
Ricky A