FREE ON-DEMAND WEBINAR

Best Practices For Medical Device Change Management: Don't Use FDA As An Excuse To Hold You Back! 

Imagine this scenario: FDA knocks on your door. They say you changed your medical device but did not tell them.

What would you do?

Unlike in the drug world, device companies make changes to existing medical devices all the time.

Sometimes they tell FDA, other times they don’t. And sometimes they get in trouble for making the wrong decision!

So how do you decide when to handle the change internally (via letter-to-file) vs. notifying FDA with a special 510k or PMA supplement?

Despite FDA issuing several guidance's, the choice isn’t always clear.

In this free 90 minute presentation, Michael Drues, Ph.D., President of Vascular Sciences, you will teach you how to make improvements to your devices while at the same time avoiding problems with FDA and liability nightmares in the future.

Most importantly, you will learn how to be prepared when the knock comes to your door!