Team

Chris Roman

Consultant

Chris has worked in the medical device industry for over 10 years with experience ranging from; design and validation of automated test systems used in medical device verification, design of next-gen medical devices, and regulatory remediation of legacy medical products.

Chris also specializes in statistical methods for verification of medical devices and statistical methods for qualification of automated test systems used in a regulated environment.

Academic & Professional Qualifications:
  • B.S., Applied Mathematics, University of Wisconsin Milwaukee
  • M.S., Applied Statistics, Pennsylvania State University
  • Certified LabVIEW Developer, National Instruments
Training, Quality Systems, & Specialties:
  • ISO 60601
  • 21 CFR 820