Regulatory Expertise

Regulatory Expertise

empirical-consulting_thumbWith experts from medical device, regulatory and tissue industries, Empirical Consulting, LLC has the connections and skills to manage your FDA and international submissions, protocols, validations and other regulatory and quality system needs.

With Empirical Consulting, LLC, 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 more than 50 years of combined experience in the medical device industry, our Empirical Consulting team knows how to help bring your medical device to market. We have established deep, long-standing relationships with regulatory agencies.

Through collaboration and consultation, we’ll guide you through the evolving and ever-changing path of achieving regulatory approval, the first time. We have proven successes throughout the world at helping our clients navigate through the process to reach their goals effectively and efficiently.

Our experts from different sectors of the medical device, regulatory and tissue industries have the connections, expertise 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)
  • Clinical literature reviews
  • Steam sterilization and cleaning validation
  • Shipping/distribution validation
  • Mechanical test protocol generation with acceptance criteria based on published literature
  • Regulatory and mechanical justification memos
  • 21 CFR 820 and ISO 13485 compliant quality systems
  • Education programs and courses
  • Literature research, paten searches, report and white paper generation
  • Audit services – internal, FDA gap analysis, ISO 9001/ISO 13485 Gap Analysis as well as supplier/vendor audits

Partner with the Empirical family of companies (Empirical ConsultingEmpirical Testing Corp. and Empirical Machine) to bring your innovative, safe and effective medical devices to market. We are the international company that will deliver exceptional service, value and support to help you gain & maintain regulatory clearance or approval.