Nicolaas Besseling

The Roots of Expertise

BesTech was founded by Nicolaas C. Besseling, a native of The Netherlands, where he received his MSEE from the University of Delft. Shortly thereafter, he joined the prestigious medical team of Dr. Christiaan Barnard in Cape Town, South Africa, as a bio-engineer.

Upon his return to The Netherlands, he designed a neo-natal lung ventilator for Hoek Loos, a local company. So, in 1980, with his core experience designing an array of medical devices, he entered the complex world of product safety issues. To facilitate those needs of cutting-edge companies, he became a member of the IEC 62D Work Group to develop safety standards for infant incubators.

In 1981, Mr. Besseling joined Siemens Medical Solutions in Amsterdam where he led the Nuclear Medicine Engineering Department and implemented the IEC 60601-1 series safety standards. By 1984, Siemens realized Mr. Besseling’s in-depth experience was needed at the company’s Hoffman Estates (Chicago) facility were he developed additional lines of nuclear medicine equipment.

Mr. Besseling left Siemens when the opportunity materialized to design medical holographic imaging equipment for a start-up company in Southern California. He decided to take his talent and experience to a significantly higher level. It was at this company where he began to implement the FDA’s Good Manufacturing Practice (GMP) requirements and developed the Voxcam, which received its 510(k) clearance just two weeks after submission.

Since 1996, BesTech Consulting Services has focused primarily on Regulatory Compliance and Product Safety for small and startup medical device companies. Mr. Besseling is active in Life Science Industry Council (LINC), Tech Coast Venture Network (TCVN), the Orange County Regulatory Affairs (OCRA) Discussion Group, and the American Society for Quality (ASQ).

FDA consulting  ·  CE-marking  ·  Medical device consulting  ·  Product development  ·  Medical device safety testing