Nothing if you aren’t willing to put the time and resources into fixing those gaps.
Less than a year ago we worked with a client and helped them to get FDA clearance on a med device product, which they got. We also provided them with a detailed gap analysis, which ultimately identified where there were gaps in relation to compliance with FDA regulations.
Now, some would say that you’ve got clearance, so start producing and selling – who cares if there are a few gaps.
Our argument at CQ is that the cost of getting a product to market the correct way far out weighs the cost of being audited in the future.Just getting a working prototype and FDA clearance does not mean that you are ready to go to market.
At this point they may or may not decide to fix those gaps, but what is the take-away for the rest of us? Well, as dad always said…
“If you are going to take the time to do something, do it right the first time!”