When you need a medical device consultant, you want a consulting company that has experience with different clients, a collection of devices, and an assortment of different problems that are to be assessed and overcome. To this end, GY Medical Device Consulting, LLC has proudly been of service to a number of clients for a variety of different consultations on different devices, and under different circumstances.

Since 2008, numerous organizations have relied on the experience, training, and expertise of Dr. Yanulis, D. Eng. as an expert witness.

The projects in which we have collaborated have been related to a number of different medical device-related subjects

  • Cardiac MRI Systems
  • Shoulder and Hip Joint Replacements
  • Heart Rate Monitoring Systems
  • Neonatal Monitoring Systems
  • Surgical Navigation Systems
  • Remote Patient Monitoring Systems
  • Implantable Cardiac Devices
  • Risk Assessment and Management
  • Document Validation
  • Defining Test Methods based off Statistical Analysis
  • Root Cause Analysis and Solutions Implementation
  • Creation and Implementation of Corrective and Preventive Action
  • Research organization, validation, and correlation
  • Execution of Final Evaluation Reports in accordance with US FDA standards
  • Review of patents, 510(k) forms, and medical device reports
  • General and specific assessment of Current Good Manufacturing Practices

We provide services across the medical device industry and are utilized successfully by a number of clients

  • B.H. Barkalow & Associates
  • GLG Informational Services (Medical Device Consultant)
  • John Laughlin, LLC
  • Hospital Health Systems
  • Cleveland Clinic’s Lerner Research Institute
  • Adam Saltman, MD
  • Other confidential medical device and healthcare organizations
Dr. George Yanulis, D. Eng.
Medical Device R&D Engineer
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