We are very grateful for the work that Third Party Review Group did on our behalf. This was our first filing as a company, and though each of in the group has been through various 510k’s in other companies this was the first time as a group we have filed.
We started in March, and finished in July. The Reviewer you assigned was spectacular. She found many omissions and inconsistencies in our first full release to TPRG. One significant one (largely due to the ISO standard changing since our predicate device did their submission). This was huge because it was a six-week test, but finding it early through our process was great.
When we were very close to the end in June, the company changed the name and the reviewer’s guidance on what we had to change (14 documents) paid off.
When the file was delivered to the FDA (4th of July week), it was impressive to get our 510k approval in 30 days with only two small issues with our labeling, that was readily fixed.
I will recommend TPRG to anyone.