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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.

ATech Designs, Inc.
Dover, New Hampshire
77 Spur Road, 03820


Contact:  Karl R. Leinsing, MSME, PE
www.atechdesigns.com
603-203-0365 Or Toll Free
kleinsing@comcast.net
77 Spur Road
Dover, New Hampshire 03820

Contact:  Karl R. Leinsing, MSME, PE
www.atechdesigns.com
603-203-0365
kleinsing@comcast.net

Karl Leinsing's CV

 

Award winning nationally recognized medical device product development expert with patent litigation and liability case experience including report writing, depositions, and trials. Experience and/or patents granted for devices in cardiovascular (AAA stents, mitral valve repair, heart remodeling, vascular assist devices), intravenous IV disposables, needle-free valves, pumps, insulin pens, syringes, catheters, surgical instruments, minimally invasive instruments, RF endometrial ablation, medical textiles, knitting, weaving, percutaneous devices, endoluminal devices, hernia repair, implants, laparoscopic staplers, laparoscopic devices, sleep apnea devices, CPAP Machines, bed rails, glucose monitors, spinal screws/plates, peritoneal dialysis, and injectors.
Information:  
Biomedical Engineering,  Engineering,  Failure Analysis,  Mechanical Engineering,  Medical,  Medical Devices,  Medical Malpractice,  Patents, 


Karl Leinsing's CV

 

Award winning nationally recognized medical device product development expert with patent litigation and liability case experience including report writing, depositions, and trials. Experience and/or patents granted for devices in cardiovascular (AAA stents, mitral valve repair, heart remodeling, vascular assist devices), intravenous IV disposables, needle-free valves, pumps, insulin pens, syringes, catheters, surgical instruments, minimally invasive instruments, RF endometrial ablation, medical textiles, knitting, weaving, percutaneous devices, endoluminal devices, hernia repair, implants, laparoscopic staplers, laparoscopic devices, sleep apnea devices, CPAP Machines, bed rails, glucose monitors, spinal screws/plates, peritoneal dialysis, and injectors.

B.H. Barkalow & Associates, LLC.
Newaygo, Michigan
65 West State Road, Suite C, 49337-8129


Contact:  Bruce H. Barkalow Ph.D., PE, CCE
www.bhbi.com
231-652-2228 Or Toll Free
travis@bhbi.com
65 West State Road, Suite C
Newaygo, Michigan 49337-8129

Contact:  Bruce H. Barkalow Ph.D., PE, CCE
www.bhbi.com
231-652-2228
travis@bhbi.com
The biomedical engineering consulting firm of B. H. Barkalow & Associates, LLC (BHBA) provides consulting and support services in areas of medical device failure (to include medical technology and software), FDA regulatory compliance, biomechanics, and patent infringements, among others. BHBA provides services to a range of clients from healthcare organizations, other consulting firms, the FDA, insurance companies, medical device manufacturers, and law firms throughout the country.
Information:  
Biomechanics,  Biomedical and Biomechanical Injury Analysis,  Biomedical Engineering,  Engineering,  Medical Devices, 


The biomedical engineering consulting firm of B. H. Barkalow & Associates, LLC (BHBA) provides consulting and support services in areas of medical device failure (to include medical technology and software), FDA regulatory compliance, biomechanics, and patent infringements, among others. BHBA provides services to a range of clients from healthcare organizations, other consulting firms, the FDA, insurance companies, medical device manufacturers, and law firms throughout the country.

Ehrreich Consulting, Inc.
Fort Myers, Florida
15640 Greenock Lane, S.E., 33912


Contact:  Stewart J. Ehrreich Ph.D.,
www.regsolutions.com
239-561-2110 Or Toll Free
SEhrreich@aol.com
15640 Greenock Lane, S.E.
Fort Myers, Florida 33912

Contact:  Stewart J. Ehrreich Ph.D.,
www.regsolutions.com
239-561-2110
SEhrreich@aol.com
Dr. Stewart Ehrreich Ph.D. Is a former Deputy Division Director at the FDA, provides litigation support in Pharmacology, Pharmacokinetics, Biostatistics, Drug Chemistry, Clinical Trials and many other areas of expertise. He has acted in many Class Action suits and Patent Litigation cases as an Expert Witness. Dr. Ehrreich has given testimony both in court and in videotaped depositions, helped to prepare expert reports and legal briefs, and advised attorneys on risk management. For almost 25 years, Ehrreich Consulting, Inc. has participated in drug development by assisting pharmaceutical companies to get their drugs, medical devices, biologics and biotechnology approved by the FDA.
Information:  
Biotechnology,  Cardiology,  Chemistry,  Dermatology,  Emergency Medicine,  Medical Devices,  Oncology,  Pharmaceuticals,  Pharmacology,  Psychopharmacology,  Sports Medicine,  Toxic Tort,  Toxicology, 


Dr. Stewart Ehrreich Ph.D. Is a former Deputy Division Director at the FDA, provides litigation support in Pharmacology, Pharmacokinetics, Biostatistics, Drug Chemistry, Clinical Trials and many other areas of expertise. He has acted in many Class Action suits and Patent Litigation cases as an Expert Witness. Dr. Ehrreich has given testimony both in court and in videotaped depositions, helped to prepare expert reports and legal briefs, and advised attorneys on risk management. For almost 25 years, Ehrreich Consulting, Inc. has participated in drug development by assisting pharmaceutical companies to get their drugs, medical devices, biologics and biotechnology approved by the FDA.

Healthcare Technology Consulting LLC
North Bethesda, Maryland
11420 Strand Drive #306, 20852


Contact:  Alan Lipschultz, CCE, PE, CSP, CPPS
www.HCTC.pro
302-584-1050 Or Toll Free
Alan@HCTC.pro
11420 Strand Drive #306
North Bethesda, Maryland 20852

Contact:  Alan Lipschultz, CCE, PE, CSP, CPPS
www.HCTC.pro
302-584-1050
Alan@HCTC.pro
HealthCare Technology Consulting LLC provides expert consulting to attorneys, healthcare facilities, manufacturers, and users of medical devices. Alan Lipschultz has over 40 years of professional experience with medical devices and Clinical Engineering. Alan is a Professional Engineer, Certified in Clinical Engineering, a Certified Safety Professional, and a Certfied Professional in Patient Safety.
Information:  
Health Care,  Hospitals,  Medical Devices,  Product Failure,  Product Liability, 


HealthCare Technology Consulting LLC provides expert consulting to attorneys, healthcare facilities, manufacturers, and users of medical devices. Alan Lipschultz has over 40 years of professional experience with medical devices and Clinical Engineering. Alan is a Professional Engineer, Certified in Clinical Engineering, a Certified Safety Professional, and a Certfied Professional in Patient Safety.

Laughlin Engineering Firm, LLC
Houston, Texas
840 Threadneedle St., #185, 77079


Contact:  John C. Laughlin M.Eng., P.E.
www.laughlinfirm.com
281-741-9226 Or Toll Free
john@laughlinfirm.com
840 Threadneedle St., #185
Houston, Texas 77079

Contact:  John C. Laughlin M.Eng., P.E.
www.laughlinfirm.com
281-741-9226
john@laughlinfirm.com
Laughlin Engineering Firm, LLC, is dedicated to providing ethical and quality biomedical and forensic engineering services to our clients. Our talented consultants provide scientific and regulatory support to medical device companies, law firms, institutional review boards, government agencies and other engineering firms.
Information:  
Accident Reconstruction,  Biomechanics,  Biomedical and Biomechanical Injury Analysis,  Human Factors,  Medical Devices,  Railroads,  Slip, Trip, and Fall, 


Laughlin Engineering Firm, LLC, is dedicated to providing ethical and quality biomedical and forensic engineering services to our clients. Our talented consultants provide scientific and regulatory support to medical device companies, law firms, institutional review boards, government agencies and other engineering firms.

Susan A. Rice and Associates, Inc.
Grass Valley, California
19816 Buck Ridge Road, 95949


Contact:  Dr. Susan A. Rice, PhD, DABT
http://www.sara-tox.com/
530-346-9612 Or Toll Free
susan.rice@sara-tox.com
19816 Buck Ridge Road
Grass Valley, California 95949

Contact:  Dr. Susan A. Rice, PhD, DABT
http://www.sara-tox.com/
530-346-9612
susan.rice@sara-tox.com
Dr. Susan A Rice has been consulting and providing expert witness services in pharmacology and toxicology for over 25 years. Dr. Rice received her PhD in Comparative Pharmacology and Toxicology from the University of California, Davis and is a Diplomate of the American Board of Toxicology. Dr. Rice researches and provides expert testimony for a broad range of products, exposures, and settings. Working with attorneys, Dr. Rice can determine if claims are likely to have resulted from alleged agents or events. She helps her clients determine if claims are scientifically and medically reasonable and to develop scientifically defensible legal strategies.
Information:  
Medical Devices,  Pharmaceuticals,  Pharmacology,  Toxic Exposures,  Toxic Tort,  Toxicology, 


Dr. Susan A Rice has been consulting and providing expert witness services in pharmacology and toxicology for over 25 years. Dr. Rice received her PhD in Comparative Pharmacology and Toxicology from the University of California, Davis and is a Diplomate of the American Board of Toxicology. Dr. Rice researches and provides expert testimony for a broad range of products, exposures, and settings. Working with attorneys, Dr. Rice can determine if claims are likely to have resulted from alleged agents or events. She helps her clients determine if claims are scientifically and medically reasonable and to develop scientifically defensible legal strategies.

V.K. Puppala, M.D.
Atlanta, Georgia
,


Contact:  V.K. Puppala, M.D.

847-340-7215 Or Toll Free
AtlantaPainMD@gmail.com

Atlanta, Georgia

Contact:  V.K. Puppala, M.D.

847-340-7215
AtlantaPainMD@gmail.com
Double board-certified in anesthesiology and pain medicine. Extensive expertise involving major catastrophic claims including airway complications, difficult intubation, intraoperative death, spine surgery complications, back pain, neck pain, herniated disc, whiplash, epidural injections, spine injection complications, painkillers, chronic opioid management, urine drug screening, addiction, overdose, failed back surgery syndrome, spinal cord stimulators, intrathecal pumps, vertebroplasty, and kyphoplasty. Extensive NIH research experience in nerve injury as well as epidural injections, spinal cord stimulation, and intrathecal pumps. Active with Medical Association of Georgia & American Society of Interventional Pain Practitioners in shaping public policy affecting pain medicine. Results-oriented with meticulous attention to detail. Excellent communication skills. Former journalism editor. Able to meet tight deadlines. Graduate of Illinois Mathematics & Science Academy, University of Illinois, and Washington University School of Medicine. Family includes a fellowship-trained addiction psychiatrist and military OB/GYN, both with extensive experience and expertise involving catastrophic claims.
Information:  
Anesthesiology,  Medical Devices,  Pain Management, 


Double board-certified in anesthesiology and pain medicine. Extensive expertise involving major catastrophic claims including airway complications, difficult intubation, intraoperative death, spine surgery complications, back pain, neck pain, herniated disc, whiplash, epidural injections, spine injection complications, painkillers, chronic opioid management, urine drug screening, addiction, overdose, failed back surgery syndrome, spinal cord stimulators, intrathecal pumps, vertebroplasty, and kyphoplasty. Extensive NIH research experience in nerve injury as well as epidural injections, spinal cord stimulation, and intrathecal pumps. Active with Medical Association of Georgia & American Society of Interventional Pain Practitioners in shaping public policy affecting pain medicine. Results-oriented with meticulous attention to detail. Excellent communication skills. Former journalism editor. Able to meet tight deadlines. Graduate of Illinois Mathematics & Science Academy, University of Illinois, and Washington University School of Medicine. Family includes a fellowship-trained addiction psychiatrist and military OB/GYN, both with extensive experience and expertise involving catastrophic claims.

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

Baretich Engineering, Inc.
Fort Collins, Colorado
P.O. Box 469, 80522-0469


Contact:  Matthew F. Baretich, P.E., Ph.D.
www.baretich.com
970-493-8239 Or Toll Free
mfb@baretich.com
P.O. Box 469
Fort Collins, Colorado 80522-0469

Contact:  Matthew F. Baretich, P.E., Ph.D.
www.baretich.com
970-493-8239
mfb@baretich.com
Matt Baretich provides clinical engineering and forensic engineering services, including incident investigation, litigation support, and expert witness services related to medical technology and healthcare facilities. He is a prolific writer and presenter, with 40 years of experience. He holds degrees in Electrical Engineering, Biomedical Engineering, and Hospital and Health Administration. He is a licensed Professional Engineer, a Certified Clinical Engineer, a Certified Healthcare Facility Manager, a Certified Professional in Healthcare Risk Management, and Certified Professional in Patient Safety.
Information:  
Biomedical Engineering,  Forensic Engineering,  Health Care,  Human Factors,  Medical Devices, 


Matt Baretich provides clinical engineering and forensic engineering services, including incident investigation, litigation support, and expert witness services related to medical technology and healthcare facilities. He is a prolific writer and presenter, with 40 years of experience. He holds degrees in Electrical Engineering, Biomedical Engineering, and Hospital and Health Administration. He is a licensed Professional Engineer, a Certified Clinical Engineer, a Certified Healthcare Facility Manager, a Certified Professional in Healthcare Risk Management, and Certified Professional in Patient Safety.

P2 Research
Flagstaff, Arizona
4090 N. Subera Lane, 86001


Contact:  George E. Pool, MPH

928-607-1140 Or Toll Free
p2research@gmail.com
4090 N. Subera Lane
Flagstaff, Arizona 86001

Contact:  George E. Pool, MPH

928-607-1140
p2research@gmail.com
Information:  
Medical Devices,