standard-title Clinical Engineering Consulting

Clinical Engineering Consulting

Medical Device Consulting Clinical Engineering

Clinical Engineering Consulting Services

Benefit from more than 25 years of R&D experience in medical devices and a Doctorate in Engineering.

The engineering of medical instrumentation devices:

  • Cardiovascular and neurological device design issues
  • Intellectual property related to medical devices and imaging systems
  • FDA medical device regulatory compliance controls
  • FDA regulatory issues of medical devices
  • FDA medical device case review
  • FDA device verification and validation

Medical device incident investigations & system failures:

  • Expert witness testimony for medical devices and medical imaging systems
  • FDA regulatory and Current Manufacturing Practices for medical systems
  • Medical device liability issues

Medical Device R&D

  • Collaborations in cardiac implantable systems
  • Intellectual property investigation support related to medical devices and medical imaging systems
  • R&D experience at the Cleveland Clinic & University of Pittsburgh

Clinical Research

  • Conducted conscious testing of animal subjects for cardiac EP research
  • Provided preoperative; operative; and post-operative cardiovascular monitoring of test subjects
  • Monitored and gathered research data during surgical implantation of cardiac pacing devices
  • Co-developed and designed all device modifications related to cardiac pacing paradigms
  • Collaborated with personnel from Data Science International on Physiology Software