Consultant certified in regulatory requirements for medical with more than twenty-five years of experience in the field of medical device firmware and software design. Specialist in safety-critical product development who has developed software as well as technical and regulatory documentation for a range of medical products under all FDA levels of concern and IEC 62304 classes. Has participated in several software submissions and inspections before the FDA and EU notified bodies. Also an inventor of technologies in the field of electronic program guides for TV set-top boxes.

Formal Education

  • B.S. in Computer Science, University of California Berkeley

Career Highlights

  • Certified in Regulatory Requirements for Medical Devices by a leading research university
  • Member of the Regulatory Affairs Professional Society (RAPS)
  • Developed embedded firmware and software as well as technical and regulatory documentation for several successful in-market medical devices under all FDA levels of concern and IEC 62304 classes
  • Performed regulatory work and architected an aortic balloon catheter with integrated blood pressure measurement and control
  • Architecture and GUI design for an ultrasonic kidney stone treatment
  • Developed processor-independent real-time motion control software for an 11-axis multi-stage wafer transfer machines for semiconductor manufacturing
  • In the mid-1990s, developed GUI and database interface code for an on-screen electronic program guide for cable converters, televisions, and satellite receivers with responsibility for product integration with equipment from various major consumer electronics manufacturers
  • Named inventor on over twenty issued U.S. patents, more than a dozen of which relate to electronic program guides for television set-top boxes

Expert Qualifications

  • As a former city councilman of a California municipality with more than 25,000 residents appeared in public meetings on live television twice a month for a dozen years
  • Testified as a witness for the prosecution in the fraud conviction of the mayor of a different California municipality
  • Testified in a hearing before the U.S. Federal Trade Commission

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Frequently Asked Questions

What types of cases can this expert support?

Medical device regulatory and design disputes. This expert has 25+ years designing firmware for FDA and EU-regulated products and can address software failures, design decisions, and compliance issues. Testimony experience includes fraud litigation and FTC proceedings.

What is this expert's technical background?

BS in Computer Science from UC Berkeley. 25+ years as a medical device firmware and software consultant—developed aortic balloon catheters, kidney stone treatment systems, real-time motion control software, and regulatory documentation for FDA and EU submissions. Holds 20+ patents.

What technologies does this expert specialize in?

C, C++, C#, assembly, embedded systems, real-time software, databases, and GUI design. Hands-on with medical device regulatory standards: FDA 510(k), IEC 62304, and ISO 13485.