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Expert in FDA Regulations for Medical Devices, QSR, Risk Management, Medical Device Design
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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Expert (MSEE) has designed medical devices and equipment for over 20 years. He helped companies develop medical devices, obtain 510(k) clearances, and comply with QSR (cGMP) for over 15 years. Expert has expertise in Risk Management per ISO 14971 and medical device safety per IEC 60601-1 (and related standards). As an FDA/device expert in medical malpractice cases, he was instrumental in obtaining substantial settlements for injured patients through a combination of QSR knowledge, engineering skills, and risk
management knowledge. Expert is originally from Amsterdam (Dutch is his first language) but has lived in the US since 1984. He speaks German and Afrikaans, and lived in South Africa for over 3 years. When residing in Cape Town, he was part of a bioengineering team assisting Dr. Christiaan Barnard, the heart transplant pioneer.
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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: Los Angeles, California;
San Diego, California;
Long Beach, California;
Santa Ana, California;
Anaheim, California;
Riverside, California;
Glendale, California;
Huntington Beach, California;
San Bernardino, California;
and Chula Vista, California.
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| Year |
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Degree |
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Subject |
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Institution |
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1972
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BS
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Electrical Engineering; Digital Electronics
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Delft University of Technology
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1974
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MS
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Electrical Engineering; Analog Electronics
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Delft University of Technology
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1993 to 1995
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Voxel
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VP of Engineering
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Developed a prototype of a holographic medical imager within two years.
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1981 to 1993
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Siemens Medical
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Nuclear Medicine
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Engineering Manager
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Developed numerous nuclear medicine systems (gamma cameras). Was in charge of mechanical engineering and Imager engineering (sequentially).
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1979 to 1981
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Hoek Loos
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Engineering Manager
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Developed neo-natal lung ventilator. In charge of the design of medical gas handling devices.
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| Selected Consulting Examples: |
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Obtained 510(k) clearance for a medical device in 88 days. The FDA had no questions or comments.
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Implemented QSR in a small CA company. The State Inspector called it the easiest inspection she had ever performed.
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A patient had been permanently injured following use of an arthroscopic surgery device. The patient sued the manufacturer of the device. Expert supported the patient's attorney as FDA and Engineering Expert. The case was settled, and the attorney wrote: ..."You were very thorough and organized in your preparation and I enjoyed working with a professional who approached the case in this manner"...
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Recent Client Requests:
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Expert in Writing a 510K.
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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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Expert Witness Experience Summary:
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Expert in several cases involving malfunctioning surgery devices. Deposed in one of these cases; all of them were settled out of court. Presented opinions pertaining to lack of FDA compliance by the medical device manufacturer, and also opinions regarding design defects.
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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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| Years |
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Country / Region |
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Summary |
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1975 to 1976
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South Africa, Cape Town
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Temporary position as Bio-Engineer at the Groote Schuur Hospital (University of Cape Town). Developed an implantable dual-heart monitor for Dr. Christiaan Barnard's research group.
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1976 to 1978
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South Africa, Sasolburg
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Instrument engineer at a chemical plant. Developed a chlorine manufacturing efficiency system.
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1979 to 1981
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The Netherlands
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Developed neo-natal lung ventilator.
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1981 to 1984
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The Netherlands
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Developed gamma cameras
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| Language Skills: |
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| Foreign Language |
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Description |
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Dutch
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Native speaker.
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German
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Used extensively when working at Siemens.
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Afrikaans
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Close to Dutch and therefore relatively easy to understand.
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| Additional Skills and Services: |
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Training/Seminars
Training seminars for Medical Device Design, Risk Management, and Risk Management as applied to Medical Device Design.
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Education
