Hi, I’m Michael H. Cohen. I’m founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness.

In today’s video, I’ll talk about legal essentials for medical device companies compliance and market success. Medical device companies as we know, have a lot of FDA regulations.

If you’re medical device, there’s different levels of medical device depending on risk. They’re regulated differently by FDA. So it’s important, first of all to really understand the FDA requirements. Recently, we helped a medical device company through the 510(k) process. Making sure that their device met the necessary standards and going toe to toe with FDA to make sure we got through.

Second: IP (Intellectual Property). Always want to protect that device, obviously to secure your market position.

And third: Quality Control, one of the things FDA looks for. So we’ve helped companies to develop their protocols to maintain product quality so that they could reduce the risk of recall and keep their brand reputation high. If you don’t pay attention to the stuff at the beginning, it becomes a big problem later.

And if you don’t have someone who really drills into your product and understands the way things can be positioned differently within the FDA regulatory categories, you’re really not taking advantage of what you need. You really need strategic legal advice.

It’s not just a dry reading of the rules. It’s about how to position your product so that you can have the best possible market entry with the least regulatory burden, and that’s what we do.

If you’d like to dive deeper into any of the topics we’ve talked about today, reach out to us. Click below. We’d love to talk to you. We look forward to it.