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Lawsonline™ Directory Expert Witness
Medical Devices
Biomedical Engineering Consultants, LLC
Houston, Texas
1111 Hermann Drive, Suite 12 B, 77004
Contact: David Yadin, P.E., Ed.D., C.C.E., C.N.A.F.E.
http://www.biomedeng.com
713-522-6666
Or Toll Free
david@biomedeng.com
Biomedical Engineering Consultants, LLC
1111 Hermann Drive, Suite 12 B
Houston, Texas 77004
Contact: David Yadin, P.E., Ed.D., C.C.E., C.N.A.F.E.
http://www.biomedeng.com
713-522-6666
david@biomedeng.com
Medical Product
Medical Equipment
Safety
Risk Analysis
Failure Analysis
Manufacturing Defect
Design Defect
Product Liability
Instruction For Use
Regulation & Compliance
Intellectual Property
Patent Infringement
Patent Litigation
Telemedicine
Maintenance
Testing & Inspection
Engineer
Pump
Monitor
Electrosurgery
Laser
Anesthesia Machine
Bed
Wheelchair
Stapler
Defibrillator
Over the past 35 years,
Dr. David
has developed, directed and taught healthcare life cycle technology management focusing on risk mitigation of medical devices and of their accessories.
Dr. David's
expertise includes successful completion of close to two hundred adverse events investigations associated with medical and surgical and telehealth products, dozens of depositions and court testimonies as a qualified expert.
Dr. David
established award-wining hospital-based technical services program and regulatory compliance knowledge supported by experience, licensure as register professional engineer in Texas, certification in clinical engineering and in the field of forensic engineering and technology. Biomedical Engineering Consultants, LLC (BEC) provides expert services in the safe and effective management of healthcare technology throughout its life cycle from development through obsolesce. As a member of the FDA advisory panel and of standards writing bodies, BEC brings unique expertise with regulatory and compliance requirements to hospitals, industry, service providers, and the legal professional.
Information:
Accident Investigations, Biomedical Engineering, Failure Analysis, Medical Devices, Patents, Product Liability, Product Warnings, Telemedicine,
Over the past 35 years,
Dr. David
has developed, directed and taught healthcare life cycle technology management focusing on risk mitigation of medical devices and of their accessories.
Dr. David's
expertise includes successful completion of close to two hundred adverse events investigations associated with medical and surgical and telehealth products, dozens of depositions and court testimonies as a qualified expert.
Dr. David
established award-wining hospital-based technical services program and regulatory compliance knowledge supported by experience, licensure as register professional engineer in Texas, certification in clinical engineering and in the field of forensic engineering and technology. Biomedical Engineering Consultants, LLC (BEC) provides expert services in the safe and effective management of healthcare technology throughout its life cycle from development through obsolesce. As a member of the FDA advisory panel and of standards writing bodies, BEC brings unique expertise with regulatory and compliance requirements to hospitals, industry, service providers, and the legal professional.
mdi Consultants, Inc.
Great Neck, New York
55 Northern Blvd. , 11021
Contact: Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001
Or Toll Free
alan@mdiconsultants.com
mdi Consultants, Inc.
55 Northern Blvd.
Great Neck, New York 11021
Contact: Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001
alan@mdiconsultants.com
Biotechnology
Business (General)
Consulting / Consultants
Food & Beverage
Food Safety
Food Safety - Hazard Analysis & Critical Control Points (HACCP)
Food Technology
Government Regulation
Healthcare (General)
Medical Devices
Medical Equipment
Pharmaceutical Medicine
Products Labeling / Warnings
Quality Assurance / Management
mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 37 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors. OUR APPROACH We utilize the following three part approach to providing high quality services to our clients: Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)
Information:
Food Manufacturing, Food Safety, Food Service, Medical Devices, Pharmaceuticals, Product Liability, Product Warnings,
mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 37 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors. OUR APPROACH We utilize the following three part approach to providing high quality services to our clients: Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)
Biomedical Business Resources, LLC
Aliso Viejo, California
, 92656
Contact: Peter Crosby
www.biomedbusiness.com
303-570-3327
Or Toll Free
peterc@biomedbusiness.com
Biomedical Business Resources, LLC
Aliso Viejo, California 92656
Contact: Peter Crosby
www.biomedbusiness.com
303-570-3327
peterc@biomedbusiness.com
Medical Devices Software
Commercially Reasonable Efforts
Patent
Intellectual Property
Product Liability
Corporate Governance
Licensing
Strategy
Inter Partes Review
Theft of Intellectual Property
Trade Secret Misappropriation
Implantable Devices
Cochlear Implants
Cardiac Pacemakers
Implantable Defibrillators
Artificial Hearts and LVADs
Neurostimulation Devices
In Vitro Diagnostics
Patient Monitoring
Imaging / Ultrasound and X-Ray)
Peter Crosby's CV
Peter Crosby
has over 40 years’ experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a Member or Chairman of the Board of 12 companies.
He is an inventor of over 40 issued US patents and foreign equivalents. He is the author or co-author of many peer reviewed scientific publications, and one novel.
His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia and intensive care, pain management, diagnostic imaging (X-Ray and ultrasound), in vitro diagnostic devices, orthopedic surgery devices, and oncology.
His product experience includes implantable devices (cochlear implants, cardiac pacemakers and defibrillators, neurostimulation, artificial heart), diagnostic ultrasound, mammography, in vitro diagnostics, patient monitoring and software including AI/ML/DL.
His business function experience includes research and development, clinical trials, regulatory approval, market launch, sales, intellectual property, merger and acquisition negotiations, licensing agreements, strategy and corporate governance.
He has extensive experience raising capital, and has been involved in the purchase or sale of several companies.
Mr. Crosby
has served as a consulting expert and testifying expert in several cases, and has written expert reports, been deposed, and testified in court or arbitration many times. Cases include intellectual property disputes such as patent infringement and IPR, alleged theft of intellectual property and trade secrets, interpretation of commercial contract terms (such as "commercially reasonable efforts"), and product liability. He has testified as an expert in the general field of the medical device industry.
Information:
Biomedical Engineering, Intellectual Properties, M and A Contract Disputes, Medical Devices, Product Liability,
Peter Crosby's CV
Peter Crosby
has over 40 years’ experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a Member or Chairman of the Board of 12 companies.
He is an inventor of over 40 issued US patents and foreign equivalents. He is the author or co-author of many peer reviewed scientific publications, and one novel.
His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia and intensive care, pain management, diagnostic imaging (X-Ray and ultrasound), in vitro diagnostic devices, orthopedic surgery devices, and oncology.
His product experience includes implantable devices (cochlear implants, cardiac pacemakers and defibrillators, neurostimulation, artificial heart), diagnostic ultrasound, mammography, in vitro diagnostics, patient monitoring and software including AI/ML/DL.
His business function experience includes research and development, clinical trials, regulatory approval, market launch, sales, intellectual property, merger and acquisition negotiations, licensing agreements, strategy and corporate governance.
He has extensive experience raising capital, and has been involved in the purchase or sale of several companies.
Mr. Crosby
has served as a consulting expert and testifying expert in several cases, and has written expert reports, been deposed, and testified in court or arbitration many times. Cases include intellectual property disputes such as patent infringement and IPR, alleged theft of intellectual property and trade secrets, interpretation of commercial contract terms (such as "commercially reasonable efforts"), and product liability. He has testified as an expert in the general field of the medical device industry.
California Heart and Lung Surgery Center
Hollywood, California
6253 Hollywood Blvd, Ste 1108, 90028
Contact: Dr. Alexander R. Marmureanu
310-208-4400
Or Toll Free
alexmhollywood@gmail.com
California Heart and Lung Surgery Center
6253 Hollywood Blvd, Ste 1108
Hollywood, California 90028
Contact: Dr. Alexander R. Marmureanu
310-208-4400
alexmhollywood@gmail.com
Alexande R Marmureanu MD's CV
Information:
Cardiology, Cardiothoracic Surgery, Cardiovascular Surgery, General Surgery, Laparoscopic Surgery, Medical Devices, Trauma Surgery, Vascular Surgery,
Alexande R Marmureanu MD's CV
William T McGee, MD, MHA
Springfield, Massachusetts
759 Chestnut Street, 01199
Contact: William T McGee, MD, MHA
413-575-7539
Or Toll Free
billtmcgee@gmail.com
William T McGee, MD, MHA
759 Chestnut Street
Springfield, Massachusetts 01199
Contact: William T McGee, MD, MHA
413-575-7539
billtmcgee@gmail.com
William T. McGee
is a professor of Medicine, Surgery and Anesthesiology @ the University of Massachusetts Medical School and a specialist in critical care medicine with interests in hemodynamic physiology, trauma, brain injury, ARDS, Safety of vascular access, sepsis, resuscitation and hospital acquired infections.
Dr. McGee
has published over 150 papers, chapters and abstracts and has been the principal investigator for clinical trials evaluating the efficacy and safety of new treatments for severe sepsis, MRSA and pneumonia, functional hemodynamics, physiologic optimization and the safety of central venous access.
Dr. McGee
was the lead enroller and author on the paper that reported the outcome of linezolid versus vancomycin for the treatment of MRSA pneumonia. He was a finalist for the Cecil Lehman Mayer Research Award from the American College of Chest Physicians for his work examining the utility of pulmonary artery catheterization in the critically ill. He was awarded the Internal Medicine Specialty Award at the Society’s 29th Scientific Symposium for research published in the Journal of American Medical Association. [Patient characteristics and ICU organizational factors that influence frequency of pulmonary artery catheterization JAMA 2000; 283:2559.]
Dr. McGee
developed the “Physiologic Optimization Program” and has published several papers on its use and care of the critically ill. [J Inten Care med 2009; Nov-Dec 24(6):352.] His copyrighted algorithm described in these papers has been distributed world-wide in 11 different languages. He is the editor of the Quick Guide to Cardiopulmonary Care published by Edwards Critical Care Education and widely used throughout the world. His research on the safe length of central venous catheters has made this procedure safer for millions of patients. Dr. McGee is board certified in Critical Care Medicine, Neuro Critical Care, Hospice and Palliative Medicine & Internal Medicine. He is presently a fellow in the society for critical care medicine, neuro critical care and chest.
Information:
Brain Injury Medicine, COVID 19, Critical Care, Critical Care Surgery, Hospitalist, Internal Medicine, Medical Case Consultation, Medical Devices, Respiratory Therapy, Surgery, Vascular Surgery,
William T. McGee
is a professor of Medicine, Surgery and Anesthesiology @ the University of Massachusetts Medical School and a specialist in critical care medicine with interests in hemodynamic physiology, trauma, brain injury, ARDS, Safety of vascular access, sepsis, resuscitation and hospital acquired infections.
Dr. McGee
has published over 150 papers, chapters and abstracts and has been the principal investigator for clinical trials evaluating the efficacy and safety of new treatments for severe sepsis, MRSA and pneumonia, functional hemodynamics, physiologic optimization and the safety of central venous access.
Dr. McGee
was the lead enroller and author on the paper that reported the outcome of linezolid versus vancomycin for the treatment of MRSA pneumonia. He was a finalist for the Cecil Lehman Mayer Research Award from the American College of Chest Physicians for his work examining the utility of pulmonary artery catheterization in the critically ill. He was awarded the Internal Medicine Specialty Award at the Society’s 29th Scientific Symposium for research published in the Journal of American Medical Association. [Patient characteristics and ICU organizational factors that influence frequency of pulmonary artery catheterization JAMA 2000; 283:2559.]
Dr. McGee
developed the “Physiologic Optimization Program” and has published several papers on its use and care of the critically ill. [J Inten Care med 2009; Nov-Dec 24(6):352.] His copyrighted algorithm described in these papers has been distributed world-wide in 11 different languages. He is the editor of the Quick Guide to Cardiopulmonary Care published by Edwards Critical Care Education and widely used throughout the world. His research on the safe length of central venous catheters has made this procedure safer for millions of patients. Dr. McGee is board certified in Critical Care Medicine, Neuro Critical Care, Hospice and Palliative Medicine & Internal Medicine. He is presently a fellow in the society for critical care medicine, neuro critical care and chest.
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