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Premarket Submission

The impact of regulatory requirements on product development timelines can be dramatic. Years can be lost due to the inability of an organization to plan and keep current on what is required to gain market clearance of their medical device or combination product in the US or EU. Planning for and executing the tasks to satisfy the requirements of FDA and EU Competent Authorities may be frustrating to understand or anticipate but they are realities that a company cannot afford to ignore. This frustration is compounded when the regulatory bodies are reviewing and changing these requirements, as in the case with the FDA and the 510(k) premarket clearance process.

RQMIS can assist you early in the development process by providing guidance with what type of preclinical testing, manufacturing, labeling and clinical information is necessary to create an effective premarket submission. Our senior management includes a former FDA reviewer who has reviewed several hundred premarket submissions, including 510(k)s, IDEs, PMAs and Reclassification Petitions. This provides RQMIS with a unique understanding of what FDA reviewers are looking for and how they prefer the submission be organized.

RQMIS consultants have authored over:

US Premarket Submissions

  • 150 510k submissions
  • 3 Original PMA’s
  • 6 Major PMA Supplements
  • 15 PMA Supplements
  • 13 original IDE submissions
  • Numerous IDE supplements
  • 2 HUDs
  • Request for Designations (RFDs)

EU Submissions

  • Design Dossiers (Active Implantables)
  • Product Submissions
  • Technical Files
  • Competent Authority Clinical Study Applications
  • Clinical Evaluation Reports