Doing or planning to do business outside of the US? Visit our sister companies. RQMIS AR LTD. or RQMIS EU SL More

FDA and EU Submission Creation and Repair

Do you know the latest (and future) requirements for obtaining market clearance in the US and EU? RQMIS knows.

Early in your product development, RQMIS 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 help you achieve regulatory clearance in a more predictable manner.

Longer term, RQMIS can consider insurance reimbursement requirements while designing clinical studies; help you produce product labeling (including indications for use and intended use) and claims that optimize sales and marketing, as well as maintain compliance with all relevant medical product regulations.

RQMIS can also negotiate with government bodies (FDA, CMS and Competent Authorities) to enhance your company's success with regulatory submissions (510(k), IDE, PMA, Design Dossiers, Canadian Licenses, etc.) and insurance reimbursement. Our consultants 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 and how to address a deficiency letter from the FDA or a Notified Body? RQMIS has been retained to interpret these deficiencies and, if necessary, "repair" regulatory submissions that may have been mishandled with the governmental bodies.

Submission Services (US):

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

Submission Services (EU):

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

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