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Accredited Psychiatry & Medicine Medical & Psychiatric Experts
Cambridge, Massachusetts
96 Larchwood Drive, 02138

Contact:  Harold J. Bursztajn, MD
www.forensic-psych.com
617-492-8366 Or Toll Free
harold_bursztajn@hms.harvard.edu
Medical & Psychiatric Experts
96 Larchwood Drive
Cambridge, Massachusetts 02138
Contact:  Harold J. Bursztajn, MD
www.forensic-psych.com
617-492-8366
harold_bursztajn@hms.harvard.edu
Dr. Bursztajn, MD continues to have an active clinical practice and consults as a forensic psychiatric expert and teaches nationally both as an individual and as a distinguished multispecialty team expert. He has had a long standing special interest in medical and psychiatric diagnosis. His publications analyzing clinical and forensic neuropsychiatric diagnosis and misdiagnosis range from the highly acclaimed book Medical Choices, Medical Chances through Analysis: DSM Biases Evident in Clinical Training and Courtroom Testimony published in the September 2007 issue of Psychiatric Annals.
Information:  
Forensic Psychiatry,  Forensic Psychology,  Medical Devices,  Medical Malpractice,  Neuropsychiatry,  Neuropsychology,  Pharmaceuticals,  Pharmacology,  Post Traumatic Stress,  Product Liability,  Psychiatric Medicine,  Psychiatry,  Psychological Autopsy,  Psychopharmacology,  Standard Practice (Suicide),  Suicide, 

Dr. Bursztajn, MD continues to have an active clinical practice and consults as a forensic psychiatric expert and teaches nationally both as an individual and as a distinguished multispecialty team expert. He has had a long standing special interest in medical and psychiatric diagnosis. His publications analyzing clinical and forensic neuropsychiatric diagnosis and misdiagnosis range from the highly acclaimed book Medical Choices, Medical Chances through Analysis: DSM Biases Evident in Clinical Training and Courtroom Testimony published in the September 2007 issue of Psychiatric Annals.

Biomedical Engineering Consultants, LLC
Houston, Texas
1111 Hermann Drive, Suite 12 B, 77004

Contact:  David Yadin
http://www.biomedeng.com
713-522-6666 Or Toll Free
david@biomedeng.com
1111 Hermann Drive, Suite 12 B
Houston, Texas 77004
Contact:  David Yadin
http://www.biomedeng.com
713-522-6666
david@biomedeng.com
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.

Martin E. Gordon, M.D., F.A.C.P., F.A.A.A.S.
Saint Louis, Missouri
One McKnight Place, Suite 437, 63124

Contact:  Martin E. Gordon

203-507-5551 Or Toll Free
martin.gordon@yale.edu
One McKnight Place, Suite 437
Saint Louis, Missouri 63124
Contact:  Martin E. Gordon

203-507-5551
martin.gordon@yale.edu
Martin E. Gordon, M.D., F.A.C.P., FACG., F.A.A.A.S., prior Clinical Professor of Medicine, Yale School of Medicine and Chairman, Board of Trustees Yale's Cushing/Whitney Medical Library Associates. Recipient of Peter Parker Dean’s Medal for contributions to medicine and Yale University.
Information:  
Gastroenterology,  Internal Medicine,  Medical Devices, 

Martin E. Gordon, M.D., F.A.C.P., FACG., F.A.A.A.S., prior Clinical Professor of Medicine, Yale School of Medicine and Chairman, Board of Trustees Yale's Cushing/Whitney Medical Library Associates. Recipient of Peter Parker Dean’s Medal for contributions to medicine and Yale University.

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
55 Northern Blvd.
Great Neck, New York 11021
Contact:  Alan Schwartz
http://www.mdiconsultants.com/
516-482-9001
alan@mdiconsultants.com
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)

The AquaMarine Group, Inc.
Redding, Connecticut
148 Gallows Hill Rd, 06896-1409

Contact:  Timothy A. Anderson, MS, MBA
www.aquamarinegroup.com
203-938-0378 Or Toll Free 203-241-5864
timothy.anderson@aquamarinegroup.com
148 Gallows Hill Rd
Redding, Connecticut 06896-1409
Contact:  Timothy A. Anderson, MS, MBA
www.aquamarinegroup.com
203-938-0378 Or Toll Free 203-241-5864
timothy.anderson@aquamarinegroup.com
I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 20+ years as a consultant in my own pharmaceutical development advisory firm, I have furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors. I have contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. I have been deposed and functioned as a Subject Matter Expert Witness in both Federal and State jurisdictions, for class action and individual cases, and I have opined on behalf of Plaintiffs and Defendants. Main phone 203-938-0378, Cell phone 203-241-5864. LinkedIn profile www.linkedin.com/in/aquamarinegroupinc/ E-mail timothy.anderson@aquamarinegroup.com
Information:  
Biomedical and Biomechanical Injury Analysis,  Chemistry,  Labels and Warnings,  Medical Devices,  Pharmaceuticals, 

I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 20+ years as a consultant in my own pharmaceutical development advisory firm, I have furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors. I have contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. I have been deposed and functioned as a Subject Matter Expert Witness in both Federal and State jurisdictions, for class action and individual cases, and I have opined on behalf of Plaintiffs and Defendants. Main phone 203-938-0378, Cell phone 203-241-5864. LinkedIn profile www.linkedin.com/in/aquamarinegroupinc/ E-mail timothy.anderson@aquamarinegroup.com

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