Global Medical Device Podcast Powered By Greenlight.guru

In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within the submission itself. The indications for use statement is not the same as within the submission itself. “There is no bigger fan of communication with the FDA. But, there is a caveat to that. That is, tell don’t ask, lead don’t follow.” - Mike Drues Today’s guest, is Mike Drues from Vascular Sciences. Mike is a professional in medical device industry for 25 years will talk about the importance of the pre-submission of medical devices to the FDA. “We need to be able to go to the FDA with a well thought out development plan.” - Mike Drues Jon and Mike have a great discussion on how to use pre-submission to bring product to market. Here are some of the specific topics you’ll hear discussed today: What is a pre-submission and why is it important. - The power o