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 Expert  107897

Expert in Medical Device Total Quality

Available for your Consulting and Expert Witness Needs

Washington (WA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
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.


FDA medical device regulation


Food and Drug Administration regulation


Good Manufacturing Practice


implantable device


medical device


medical device manufacturing


medical electrode

Show Secondary and Basic Areas of Expertise
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.

Often requested
with this expert:

Biomedical Engineering, Manufacturing Engineering, R&D
Medical Device Design and Analysis
Medical Devices; Product Development, Manufacturing,...
Product Approval and GMP Compliance to Medical Device...

Year   Degree   Subject   Institution  
1977   MS   Biomedical Engineering   South Dakota State University  
1974   BS   Engineering Physics   South Dakota State University  

Work History:
Years   Employer   Title   Responsibilities

1993 to




Managing Partner


Expert provides medical device consulting, process validation, design control, risk management, and quality systems design.

1992 to 1992


Integrated Surgical Systems


RA/QA Director


1991 to 1992


WYKO Corporation


Business Development


1985 to 1991


First Medic


Product Development


1983 to 1985


Cardiac Resuscitator Corporation


Vice President, Technical Operations


1979 to 1983


Medical Technology Inc./Biotronic Sales Inc.


Director, Product Development


1977 to 1979


U.S. Food & Drug Administration


Biomedical Engineer


Career Accomplishments:

Expert is a member of ASQ (former Chair), AAMI, RAPS (RAC), and IEEE.


He is an RAB certified lead auditor, and has ASQ/CQA certification.

Professional Appointments

He is the Publications Chair for the ASQ biomedical division.

Publications and Patents Summary

He has five publications relating to medical devices.

Selected Publications and Publishers  
 - Medical Instrumentation  
 - Journal of the Americam College of Cardiology  
 - Scanning Microscopy  
 - Quality Press  

Government Experience:
Years   Agency   Role  
1977 to 1979   U.S. FDA   Biomedical Engineer  

Consulting Services:
Selected Consulting Examples:
  • Expert is a quality system consultant for medical device manufacturers.
  • He implements process validation programs and conducts qualifications.
  • He consults in product design and implements design control systems.
Recent Client Requests:
  • Fda medical device mock audit for consulting on Mock audit to 21CFR820.
  • Expert in medical affairs/safety for consulting on requirements for medical device Reportable events, reporting requirements for UADE in the US and EU.
  • Expert in pacemaker signaling
  • Packaging validation expert for consulting on document.
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.

Expert Witness:
Recent Litigation Client Requests:
  • Expert for consulting on FDA medical device regulation.
  • Pacemaker bio engineering expert for consulting on heart device litigation.
  • Medical device and FDA industry standard compliance expert for consulting on proper cleaning instructions for an endoscope holder.
  • Expert for consulting on defibrillator.
  • Medical device expert for consulting on expert witness.
  • New jersey Cardiac Electrophysiologist expert Witness for consulting on icd implantation and informed consent.
  • Cardiac electrophysiology expert witness for consulting on proper defibrillator (AED) maintenance.
  • Expert witness in FDA investigational medical devices for consulting on pulmonary vein isolation ablation catheters, mapping systems and navigational devices.
  • Expert in manufacturing of artificial hearts for consulting on the sterilization/ re-sterilization process due to power failure.
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.

International Experience:
Years   Country / Region   Summary
1990 to 2002   Europe   Expert consulted for various EU medical device manufacturers in Ireland, Germany, the U.K., Italy, etc.
2001 to 2001   Far East/Japan   He provided consulting for medical devices companies.

Language Skills:
Foreign Language  

Additional Skills and Services:

Expert conducts training in process validation, design control, GMP, and risk managment.


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