Regulatory Product Classifications & Submissions

Your team has developed a medical device that could revolutionize healthcare. You now need support to bring a concept through the FDA. This is where our regulatory affairs consultants become your ally.

Compliance Team’s regulatory affairs experts will help you to classify your product to determine whether it meets the legal requirements of a “medical device,” meaning that it is subject to registration and listing requirements. If the product is a medical device or an invitro-diagnostic, Compliance Team can help classify it as Class I, Class II, Class III or de Novo listings, and identify the registration and listing requirements applicable to your product.

Furthermore, Compliance Team offers Regulatory Affairs consulting to document the submission for Class I (Registration/Listing only ), Class II (510(k)), Class III or de Novo (PMA).  We will also assist by identifying the extent of supporting documentation and data needed for smooth clearance of your application.  And, of course, we can facilitate any pre-submission meetings with the FDA to ensure that all parties are aware of the intricacies of the product submission process.

In the long run, our services will save your company money by allowing your product to reach the market more quickly and by minimizing wasted time and resources.

Let us show you how to legally sell your new medical product in the United States at maximized ROI.