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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.

Maronick Associates
Baltimore, Maryland
5911 Charlesmead Road, 21212


Contact:  Thomas J. Maronick, DBA, JD
www.adexpert.net
410-435-8387 Or Toll Free
maronick@verizon.net
5911 Charlesmead Road
Baltimore, Maryland 21212

Contact:  Thomas J. Maronick, DBA, JD
www.adexpert.net
410-435-8387
maronick@verizon.net
Dr. Thomas J. Maronick, DBA, JD is the former Director of the Office of Impact Evaluation in the Bureau of Consumer Protection at the Federal Trade Commission. He was the in-house marketing and advertising expert for all Divisions of the Bureau of Consumer Protection for over 16 years.
Information:  
Advertising,  Consumer Products,  False Accusations,  Forensic Marketing,  Labels and Warnings,  Marketing,  Multi Level Affiliate Marketing,  Product Liability,  Product Warnings,  Surveys and Assessments,  Trademark, 


Dr. Thomas J. Maronick, DBA, JD is the former Director of the Office of Impact Evaluation in the Bureau of Consumer Protection at the Federal Trade Commission. He was the in-house marketing and advertising expert for all Divisions of the Bureau of Consumer Protection for over 16 years.

J.M. Miller Engineering, Inc.
Ann Arbor, Michigan
2392 Fuller Court, 48105


Contact:  J.M. Miller
www.millerengineering.com
734-662-6822 Or Toll Free
miller@millerengineering.com
2392 Fuller Court
Ann Arbor, Michigan 48105

Contact:  J.M. Miller
www.millerengineering.com
734-662-6822
miller@millerengineering.com
Dr. Miller is an Emeritus Professor at the University of Michigan College of Engineering and a registered professional engineer and consultant with over 30 years of experience as an engineering expert witness. He specializes in warnings, labeling and instruction manuals, consumer product design, machine guarding, process safety, fire science, vehicle visibility, tractor egress/ingress, pedestrian and worker slip and fall prevention, COF testing, recreational vehicle safety (boats, ATVs and personal watercraft), compliance with occupational safety and consumer safety standards (OSHA, MSDS, ANSI, ASTM, UL, CPSC).
Miller Engineering has a staff of engineers and experts in the Mechanical, Chemical, Agriculture, Industrial, and Human Factors Engineering.
Dr. Miller has recently authored a chapter titled Hazard Communication Compliance in the Safety Engineering Handbook for ASSE. Dr. Miller has authored five books on the topic of Warnings and Safety Instructions and hundreds of journal articles. He is also currently a committee member of the ASTM Technical Committee F15 on Consumer Products.
Dr. Miller’s experience includes the following: Bachelor of Mechanical Engineering (1963), M.B.A. (1965), and Ph.D. in Industrial Engineering (1971), Ohio State University. Owens-Corning Fiberglass (1964-1967): Corporate Methods Engineer. The University of Michigan (1970-present): Industrial and Operations Engineering (IOE) Professor, teaching courses in human factors/ergonomics, safety, engineering law, and labor relations. U.S. Department of Labor (1975-1977): Special Assistant for Safety, Assistant Secretary of Labor.
Information:  
Accident Investigations,  Accident Reconstruction,  Agricultural Engineering,  Construction Safety,  Consumer Products,  Ergonomics,  Fire and Explosions,  Forklifts,  Human Factors,  Industrial Accidents,  Labels and Warnings,  Mechanical Engineering,  OSHA,  Personal Injury,  Product Warnings,  Slip, Trip, and Fall,  Toxic Exposures,  Toy Safety Design,  Transportation,  Work Zone and Flagger Safety, 


Dr. Miller is an Emeritus Professor at the University of Michigan College of Engineering and a registered professional engineer and consultant with over 30 years of experience as an engineering expert witness. He specializes in warnings, labeling and instruction manuals, consumer product design, machine guarding, process safety, fire science, vehicle visibility, tractor egress/ingress, pedestrian and worker slip and fall prevention, COF testing, recreational vehicle safety (boats, ATVs and personal watercraft), compliance with occupational safety and consumer safety standards (OSHA, MSDS, ANSI, ASTM, UL, CPSC).
Miller Engineering has a staff of engineers and experts in the Mechanical, Chemical, Agriculture, Industrial, and Human Factors Engineering.
Dr. Miller has recently authored a chapter titled Hazard Communication Compliance in the Safety Engineering Handbook for ASSE. Dr. Miller has authored five books on the topic of Warnings and Safety Instructions and hundreds of journal articles. He is also currently a committee member of the ASTM Technical Committee F15 on Consumer Products.
Dr. Miller’s experience includes the following: Bachelor of Mechanical Engineering (1963), M.B.A. (1965), and Ph.D. in Industrial Engineering (1971), Ohio State University. Owens-Corning Fiberglass (1964-1967): Corporate Methods Engineer. The University of Michigan (1970-present): Industrial and Operations Engineering (IOE) Professor, teaching courses in human factors/ergonomics, safety, engineering law, and labor relations. U.S. Department of Labor (1975-1977): Special Assistant for Safety, Assistant Secretary of Labor.

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)