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Expert in Medical Device Total Quality
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of Expert Consulting Inc., a company specializing in process validation, FDA/regulatory consulting, and auditing. He is considered one of the national experts in process validation and design control for medical device manufacturers. A biomedical engineer, Expert has experience in a number of medical device manufacturers including heart pacemakers and defibrillators and he also was a Field Engineer with the U.S. Food and Drug Administration. He works primarily with implantable or life-sustaining products. His experience with FDA regulations is particularly useful in helping with the speedy approval of medical devices. In addition, his experience has fostered contacts with the FDA leading to a positive relationship. MEDICAL ELECTRODES. During his career, Expert has been directly involved in the development and clinical use of medical electrodes, particularily polymer electrodes for use with external defibrillators and pacemakers. IMPLANTABLE DEVICES. Expert has played an integral part in the development of cardiac pacemaker products for both internal and external applications, of external automatic defibrillators, and of other implantable devices. MEDICAL DEVICE MANUFACTURING; GOOD MANUFACTURING PRACTICE. Expert's knowledge of manufacturing requirements also helps in the development of manufacturable products. He has overseen several products through the development cycle to marketing. He is very familiar with good manufacturing practice systems for medical device manufacturing. He is presently using his expertise to assist a computer-controlled surgical device company in all of these areas. Other related specialties for Expert include pacemaker products and medical hybrid-circuit quality assurance.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Seattle, Washington;
Tacoma, Washington;
Bellevue, Washington;
Everett, Washington;
Federal Way, Washington;
Kent, Washington;
Bellingham, Washington;
Lakewood, Washington;
and Renton, Washington.
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Degree |
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Subject |
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Institution |
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1977
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MS
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Biomedical Engineering
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South Dakota State University
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1974
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BS
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Engineering Physics
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South Dakota State University
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Employer |
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Title |
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Responsibilities |
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1993 to
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(Undisclosed)
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Managing Partner
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Expert provides medical device consulting, process validation, design control, risk management, and quality systems design.
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1992 to 1992
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Integrated Surgical Systems
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RA/QA Director
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1991 to 1992
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WYKO Corporation
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Business Development
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1985 to 1991
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First Medic
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Product Development
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1983 to 1985
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Cardiac Resuscitator Corporation
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Vice President, Technical Operations
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1979 to 1983
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Medical Technology Inc./Biotronic Sales Inc.
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Director, Product Development
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1977 to 1979
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U.S. Food & Drug Administration
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Biomedical Engineer
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Associations/Societies
Expert is a member of ASQ (former Chair), AAMI, RAPS
(RAC), and IEEE.
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Licenses/Certifications
He is an RAB certified lead auditor, and has ASQ/CQA certification.
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Professional Appointments
He is the Publications Chair for the ASQ biomedical division.
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| Publications: |
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Publications and Patents Summary
He has five publications relating to medical devices.
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Selected Publications and Publishers
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- Medical Instrumentation
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- Journal of the Americam College of Cardiology
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- Scanning Microscopy
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- Quality Press
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| Government Experience: |
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Agency |
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Role |
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1977 to 1979
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U.S. FDA
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Biomedical Engineer
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| Selected Consulting Examples: |
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Expert is a quality system consultant for medical device manufacturers.
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He implements process validation programs and conducts qualifications.
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He consults in product design and implements design control systems.
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Recent Client Requests:
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Fda medical device mock audit for consulting on Mock audit to 21CFR820.
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Expert in medical affairs/safety for consulting on requirements for medical device Reportable events, reporting requirements for UADE in the US and EU.
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Packaging validation expert for consulting on document.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Recent Litigation Client Requests:
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Expert for consulting on FDA medical device regulation.
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Pacemaker bio engineering expert for consulting on heart device litigation.
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Medical device and FDA industry standard compliance expert for consulting on proper cleaning instructions for an endoscope holder.
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Expert for consulting on defibrillator.
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New jersey Cardiac Electrophysiologist expert Witness for consulting on icd implantation and informed consent.
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Cardiac electrophysiology expert witness for consulting on proper defibrillator (AED) maintenance.
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Expert witness in FDA investigational medical devices for consulting on pulmonary vein isolation ablation catheters, mapping systems and navigational devices.
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Expert in manufacturing of artificial hearts for consulting on the sterilization/ re-sterilization process due to power failure.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Summary |
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1990 to 2002
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Europe
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Expert consulted for various EU medical device manufacturers in Ireland, Germany, the U.K., Italy, etc.
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2001 to 2001
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Far East/Japan
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He provided consulting for medical devices companies.
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| Language Skills: |
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| Additional Skills and Services: |
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Training/Seminars
Expert conducts training in process validation, design control, GMP, and risk managment.
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Education
