Global Regulatory Filing

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Based on your medical device classification and current stage of development, there are a variety of submissions that may be required by regulatory agencies in the US, Europe, Canada, and throughout the globe. Utilizing strategies designed to address regulatory concerns and minimize additional questions, our team reviews, prepares and submits documents required for appropriate medical device regulatory pathways.

Our team has prepared and submitted hundreds of successful medical device regulatory documents, including:

  • Medical device 510(k) registration for Class 1, 2, 3, de Novo
  • Premarket Approval Applications (PMAs)
  • Pre-submission support documents
  • US FDA Quality System Regulation (FDA QSR)
  • Investigational Device Exemption Applications (IDEs)
  • 513(g) Requests for Classification
  • QMS compliance: ISO 13485, and 21 CFR part 820
  • Technical files/ design dossiers for CE Mark
  • Canadian License Applications
  • FDA and CE Marking QMS Audits
  • Rescue and remediation compliance services