Expert in FDA Regulations for Medical Devices, QSR, Risk Management, Medical Device Design

Available for your Consulting and Expert Witness Needs

California (CA)
USA

Education

Work History

Consulting Services

Expert Witness

Summary of Expertise:

Listed with other top experts in:

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.

•	510(k) document
•	electronic medical device
•	electronic medical device design
•	Food and Drug Administration compliance
•	FDA medical device regulation
•	foreign language
•	medical device
•	medical device design
•	medical device evaluation
•	medical device hazard analysis
•	medical device product development
•	medical equipment
•	medical product
•	nerve stimulator
•	transcutaneous electrical nerve stimulator

Show Only Primary Areas of Expert Consulting

Secondary Expertise
CE Marking, Current Good Manufacturing Practice, disposable infusion pump, durable medical equipment, electronic equipment design, Food and Drug Administration, Good Manufacturing Practice, governmental registration process, International Electrotechnical Commission 601, international manufacturing, international organization, international technology transfer, mechanical respirator, medical device auditing, medical device manufacturing quality control, medical device product improvement, Medical Device Reporting regulation, medical device safety, medical device testing, medical product manufacturing, medical technology, medical X-ray equipment, stent

Basic Expertise
antimicrobial medical device, bioburden, biocompatibility, biocompatibility testing, catheter, defibrillator, disposable medical device, European Union Authorized Representative, failure modes and effects analysis, fault tree analysis, foreign medical device regulation, Good Clinical Practice, Good Laboratory Practice, implantable device, medical device clinical research, medical device inspection, medical device irradiation sterilization, medical device liability, medical device manufacture clean room, medical device manufacturing, medical device manufacturing troubleshooting, medical device marketing, medical device package integrity, medical device package testing, medical device packaging design, medical device packaging material, medical device packaging process, medical device premarket approval, medical device process validation, medical device reliability testing, medical device reporting, medical liability, medical malpractice evaluation, medical software quality assurance, needle, package design, packaging material

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.

Education:

Year	Degree	Subject	Institution
1972	BS	Electrical Engineering; Digital Electronics	Delft University of Technology
1974	MS	Electrical Engineering; Analog Electronics	Delft University of Technology

Work History:

Years	Employer	Department	Title	Responsibilities
1993 to 1995	Voxel		VP of Engineering	Developed a prototype of a holographic medical imager within two years.
1981 to 1993	Siemens Medical	Nuclear Medicine	Engineering Manager	Developed numerous nuclear medicine systems (gamma cameras). Was in charge of mechanical engineering and Imager engineering (sequentially).
1979 to 1981	Hoek Loos		Engineering Manager	Developed neo-natal lung ventilator. In charge of the design of medical gas handling devices.

Consulting Services:

Selected Consulting Examples:

Obtained 510(k) clearance for a medical device in 88 days. The FDA had no questions or comments.
Implemented QSR in a small CA company. The State Inspector called it the easiest inspection she had ever performed.
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"...

Recent Client Requests:

Expert in Writing a 510K.

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:

Expert Witness Experience Summary:

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.

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
1975 to 1976	South Africa, Cape Town	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.
1976 to 1978	South Africa, Sasolburg	Instrument engineer at a chemical plant. Developed a chlorine manufacturing efficiency system.
1979 to 1981	The Netherlands	Developed neo-natal lung ventilator.
1981 to 1984	The Netherlands	Developed gamma cameras

Language Skills:

Foreign Language		Description
Dutch		Native speaker.
German		Used extensively when working at Siemens.
Afrikaans		Close to Dutch and therefore relatively easy to understand.

Additional Skills and Services:

Training/Seminars

Training seminars for Medical Device Design, Risk Management, and Risk Management as applied to Medical Device Design.


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