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Regulatory Submissions

Early in your product development, our team of medical device expert consultants can provide guidance on what type of preclinical testing, manufacturing, labeling, and clinical information will be necessary to obtain premarket clearance. Having this information early in the development cycle can make the rest of the regulatory process flow more predictably - saving you both time and money.

Longer term, we can consider the implications of future insurance reimbursement requirements while designing your clinical studies. To optimize your sales and marketing efforts we can help you to produce product labeling (including indications for use and intended use) and claims as well as maintain compliance with all relevant medical product regulations.

One of the scariest parts of gaining regulatory clearance is having to negotiate with the government bodies in your chosen market (i.e. FDA, Notified Bodies, etc). Our experienced team of regulatory experts in medical devices will negotiate on your behalf, which we've found enhances a company's chance of success tenfold. These subject matter experts include a former senior scientific reviewer in the FDA's Office of Device Evaluation. Having the perspective of a former FDA reviewer allows RQMIS to understand "both sides of the fence" during the FDA review.

Struggling to understand how to address a deficiency letter from the FDA or a Notified Body related to your medical device submission? We're here to interpret these deficiencies and if necessary, "repair" regulatory submissions that may have been mishandled by the governmental bodies.

We offer support for the following types of submissions in the United States market:

  • FDA 510k Submissions for Obtaining FDA Clearance
  • FDA 513(g) Submissions for Obtaining a Classification Ruling from the FDA
  • FDA Pre-Investigational Device Exemption (Pre-IDE) Consulting
  • FDA DeNovo Submission Support for Medical Device Companies
  • FDA Premarket Approval (PMA’s)
  • FDA Investigational Device Exemption (IDE’s)
  • FDA Request for Designation (RFD’s)
  • FDA Humanitarian Use Designation (HUD)
  • FDA Humanitarian Device Exemption (HDE)
  • MDSAP Program

We can also assist you with the following submissions in European Union territories:

  • Design Dossiers
  • Product Submissions
  • Technical Files (EU market)
  • Clinical Evaluation Reports (CERs)

In addition to what is listed above, we offer various forms of regulatory support all around the globe. We have successfully assisted clients with their regulatory clearances in South America, Canada, Japan, South Korea, and Australia.

Not sure what document to submit?

Our experienced consultants can point you in the right direction. Call us today at (978) 358-7307, or just click here:

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