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November 17, 2022

Regulatory Due Diligence: Why Pay for Information You Can Get for Free?

It’s staggering to see how many companies (and the people in them) embarrass themselves when going to FDA unprepared, i.e., not knowing the most basic information. Not only is this seen as unprofessional, but it does not instill a high degree of confidence that the company and the people in it know what they are doing.

And when it comes to developing medical devices, this is not an image you want to present to the FDA!

Being well prepared, i.e., doing your homework a.k.a. regulatory due diligence, is the best way to mitigate or even eliminate this risk. It’s also your responsibility as a medical device professional!

But what is regulatory due diligence and how do you do it? More importantly, how do you use it to your strategic advantage? You can pay a regulatory consultant to do it for you but why do that when, with the right skills, you can do it yourself – and use the money you saved for more important things like to develop your regulatory strategy instead?

Regulatory due diligence is like a scalpel: when used in the hands of a skilled surgeon, it can be a very useful tool. But when used by someone who doesn’t know what they are doing, it can cause a lot of damage and harm. So which group would you like to be in?