Regulatory & Reimbursement Core

Our Regulatory Core provides extensive regulatory, reimbursement, and quality assurance capabilities. On-site expertise is provided by PDC Clinical-Regulatory Engineer Alex Balus, who assists innovators with FDA inquiries and submissions and provides up-to-date advising on FDA guidances and initiatives, such as the use of real-world evidence in FDA regulatory filings. In addition, the PDC works closely with the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) to provide education opportunities for pediatric device innovators.

  • CDRH Learn: Video-based learning modules covering a range of topics such as regulatory overview, device classification, postmarket activities, and industry basics. The tool is intended to provide useres with information that is comprehensive, interactive, and easily accessible. View the modules here.
  • FDA Device Advice: The FDA's Center for Devices and Radiological Health (CDRH) offers comprehensive regulatory assistance through text-based resources that explain medical device laws, regulations, guidances, and policies, covering both premarket and postmarket topics. View the resources here.

Advisors:

  • Michael Billig - CEO, Experien Group LLC - website
  • Linda Braddon, PhD - CEO, Secure BioMed Evaluations - website
  • Thomas Lawson, PhD - Principal Consultant, Lawson & Associates
  • Susan Rowinski, MSE - President & Founder, Rowinski Group LLC - website