Dr. George Yanulis, M.E, M.S., D.Eng.
Areas of Expertise: Biomedical Engineering; Medical Devices
Dr. Yanulis is a Medical Device Product Development and Research Engineer and possesses an M.Eng., M.S., D.Eng. (all in biomedical engineering) and has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. And has both published and has an on-going interest in the research and development (R&D) of medical devices used in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.
Litigation Support/Medical Device R&D/Consulting –
Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years. He has been a R&D Engineer at the Cleveland Clinic Foundation and has worked with EP cardiologists and clinicians at the University of Pittsburgh Medical Center (UMPC), University of Virginia (UVA) and the Mount Sinai Health System. He has provided testimony in 10 depositions and one trial in the last 4 years (without a Daubert Challenge) and has been an Expert Witness and medical device consultant for over 20 years and has been involved in numerous medical device liability and patent infringement cases for both the Plaintiff and the Defendant sides. He has been involved in cases involving and has provided his advice and expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. And Dr. Yanulis has:
- Expertise in Implantable Cardiac Defibrillator (ICD) and cardiac pacemaker devices R&D
- Expertise PET imaging systems
- Expertise in serving as an Expert Medical Device Witness
- Has mentored over 500 biomedical engineering students
- Expertise in Cardiac Ultrasound Imaging
- Expertise & Cardiac MRI Expertise
- Has IP Medical Systems/Products Expertise
- Biomaterials & Tissue Engineering Expertise
- Has reviewed MDR(s) and other adverse events related to implant device failure
- Expertise in ISO 14971 Automated Risk Analysis & Management Software
- Expertise 21 CFR Part 820, the FDA quality system regulation (QSR)
- Involved in assessing GCMP practices used for implant system failures
- Expertise in Surgical Navigation Systems
- Expertise in all types Orthopedic Implant Systems
- Mentoring Biomedical Engineering Students in both biomaterials and tissue engineering
- Expertise in Preclinical and Clinical Device Trials
- And has six peer review publications in heart failure therapy device and development.
- Expertise in Implantable Cardiac Defibrillator (ICD) and cardiac pacemaker devices R&D
- Expertise PET imaging systems
- Expertise in serving as an Expert Medical Device Witness
- Has mentored over 500 biomedical engineering students
- Expertise in Cardiac Ultrasound Imaging
- Expertise & Cardiac MRI Expertise
- Has IP Medical Systems/Products Expertise
- Biomaterials & Tissue Engineering Expertise
- Has reviewed MDR(s) and other adverse events related to implant device failure
- Expertise in ISO 14971 Automated Risk Analysis & Management Software
- Expertise 21 CFR Part 820, the FDA quality system regulation (QSR)
- Involved in assessing GCMP practices used for implant system failures
- Expertise in Surgical Navigation Systems
- Expertise in all types Orthopedic Implant Systems
- Mentoring Biomedical Engineering Students in both biomaterials and tissue engineering
- Expertise in Preclinical and Clinical Device Trials
- And has six peer review publications in heart failure therapy device and development.
Reference:
- Medical Device Consulting Billing Rates
- Medical Device Consulting and Research Expertise
- Cardiovascular Device Expertise
- Medical Device Engineer Consulting Profile
- Depositions and Trial Testimony
- Publications and Presentations
- Selected Portion Medical Device Case List Summary
- Professional References
Also see Dr. Yanulis on LinkedIn