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With Empirical Consulting, you’ve found the partner you need to gain and maintain U.S. and international regulatory clearance and approval once your medical device design is complete.

With almost 50 years of combined experience in the medical device industry, the Empirical Consulting team knows how to help bring your medical device to market. Our experts from different sectors of the medical device, regulatory and tissue industries have the connections and skills to help you succeed. For the entire Empirical Consulting team, perfection is priority.

Partner with Empirical Consulting for:

  • 510(k) submissions for devices to be sold in the U.S., including combined tissue/device products
  • Technical files for devices to be sold internationally (CE marking)
  • Steam sterilization validation
  • Shipping/distribution validation
  • Mechanical test protocols, including acceptance criteria based on published literature
  • Regulatory and mechanical justification memos
  • 21 CFR compliant quality systems
  • ISO 13485 compliant quality systems
  • Clinical literature reviews
  • Compliance support
  • Complete quality systems, including AATB/21 CFR 1271 compliance and client-specific SOP authoring
  • Audit services – internal AATB STAR audits, FDA gap analysis and ISO 9001/ISO 13485 Gap Analysis as well as supplier/vendor audits

Partner with the family of Empirical companies (Empirical Consulting, Empirical Testing Corp. and Empirical Machine) to bring your innovative, safe and effective medical devices to market. We’re here to help you gain and maintain regulatory approval.