Clinical Engineering Consulting

When you work with GY Medical Device Consulting, LLC, you have access to the expertise of an organization with more than 25 years of R&D and consultation experience with medical devices. This experience comes from a long career of working in the medical device industry, as well as the advanced applications provided through the possession of a Doctorate of Engineering.

The education and expertise present within our organization have rewarded us with experience working within the following disciplines related to medical devices and clinical research:

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

To better understand how our experience and expertise in clinical engineering consulting, whether for research, development, incident investigations, or general best engineering practices, please let us and we will be more than happy to speak with you!

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