George Yanulis - Medical Device Consulting, LLC

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Contact Information

George Yanulis

Medical Device Consulting, LLC

7921 Reflection Cove Drive

Fort Myers, FL 33907

(216) 571-1532

Expert Witness
  • Intellectual Property
  • Failure Analysis
  • Engineering
  • About
  • Background
  • Reviews
  • Colleagues
  • Documents

 Areas of Medical Device Expertise 

Biomedical Engineering Research & Development

Medical Device Expert Witness

Medical Devices Research & Development (R&D)

R&D Bridge to transplantation devices for patients in heart failure

Food & Drug Medical (FDA) Device Regulatory Protocols

Echocardiography

Cardiac MRI

Cardiac Electrophysiology (EP)

Interventional Cardiology 

Orthopedic Device Implants

Clinical Engineering

Heart Failure Studies

Atrial Fibrillation Studies

Therapeutic Radiological Physics 

Nuclear Cardiology

Pediatric Critical Care Medicine Devices

Medical Polymers & Plastics

Medical Device Failure Analysis

Litigation Support/Medical Device Research & Development /Consulting

Cleveland Clinic Foundation (cardiac pacing paradigm studies for heart failure patients

Cleveland Clinic Foundation (cardiac pacemaker studies) 

University of Pittsburgh Medical Center (Dielectrictic Elastomeric Polymer Studies)

Mount Sinai Health System (Surgical Wound Repair Studies) 

Provided testimony in 6 depositions in the last 4 years (without a Daubert Challenge) 

Involved in over medical device liability and patent infringement cases 

Provides advice and expertise to attorneys 

Performed over 500 ECG signal detection & cardiac pressure/volume analysis 

Provides biomedical engineering analysis and fabrication of cardiovascular devices

Expertise in evaluating Quality Assurance Testing and Results for cardiac device systems

Expert on cardiac pacemaker and ICD devices 

Evaluation of cardiac pacing and ICD lead/system failures

Reviews cardiac pacing and ICD monitoring sessions as an Expert Witness 

Selected Publications

1. Lim, Pascal; George E. Yanulis; David Verhaert; Neil L. Greenberg; Richard A. Grimm; Patrick J. Tchou; Nicolas Lellouche; and Don W. Wallick. Coupled Pacing Improves Left Ventricular Function during Simulated Atrial Fibrillation without Mechanical Dyssynchrony. Euro pace. 2010 Mar; 12(3): 430-6.

2. Yanulis, George E.; Pascal Lim; Ali Ahmad; Zoran B. Popović; and Don W. Wallick. Coupled Pacing Reverses the Effects of Persistent Atrial Fibrillation on the Left Ventricle. The Annals of Thoracic Surgery. 2008 Sep; 86(3): 984-7.

3. Yanulis, George E. A Novel Cardiac Pacing Paradigm for Atrial Fibrillation and Heart Failure Patients. Doctoral dissertation, Fenn College of Engineering, Cleveland State University. 2008 May; 1-106.

4. Cingoz, Faruk; George E. Yanulis; Elizabeth Ching; Kiyotaka Fukamachi; and Don W. Wallick. Use of Conventional Dual Chamber Pacemakers with Custom Lead Adapters to Induce Atrial Fibrillation or Heart Failure in Dogs. The Annals of Thoracic Surgery.2007 May; 83(5): 1858-62.

 

Professional
 
Undergraduate: Syracuse University
Law School:
Practice Areas: Expert > Materials Science
Expert > Engineering
Expert > Failure Analysis
Expert > Intellectual Property
Organizations: IEEE Engineering in Medicine & Biology Society Pharmaceutical, Medical Device & Biotech Subcommittee of the ABA Heart Rhythm Society The Association for the Advancement of Medical Instrumentation
   
Personal
 
Gender: Male
Status: Single
Children: No Children
Age: 64
City of Residence: Fort Myers
Home Town:
Home State: FL
   
Interests
 
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No Reviews

No Colleagues.

EAS Webinar: FDA’s Transition from CFR 820 to the ISO 13485:2016 - Instituting a New Quality Management System (QMS) September 25, 2019 Presented by George Yanulis, D.Eng., EAS Independent Consultant FDA’s shift to a to a Quality System Regulation structure of ISO 13485:2016 is an effort to harmonize medical device regulations as well as reduce compliance and record keeping burdens faced by current medical device manufacturers. But will those operating under 21 CFR 820 Quality Management Systems made the voluntary switch? While ISO 13485 is an international standard, its focus on design
Posted by George Yanulis on 10.8.19 in Miscellaneous.

Dr. George Yanulis earned a Doctor of Engineering Degree (D.ENG.) in Biomedical Engineering from a joint program offered through the Washkewicz College of Engineering at Cleveland State University and the Cleveland Clinic Foundation (CCF). Dr. Yanulis is an experienced medical device research and development engineer and medical device expert witness and has extensive experiences and expertise in medical device research and development for all types of medical devices and medical imaging systems.
Posted by George Yanulis on 10.8.19 in Employment.