I am an expert consultant in International Medical Device Regulations. I was a founder of the Notified Body KEMA Quality in The Netherlands and served many years as Certification Manager for medical devices.
I earned my degrees in physics and chemistry at the University of Utrecht.
In 1975, I was appointed as a clinical physicist for Radiation Therapy and Nuclear Medicine at the Free University of Amsterdam and was elected to the board of directors of the medical faculty four years later.
In 1983, I was appointed as manager of the Department of Biomedical Engineering and Clinical Physics at the University hospital. From 1988 until 1992 I was responsible for the qualification of Hospital Physicists in the Netherlands.
In 1992 KEMA (now part of Dekra) invited me to initiate Notified Body activities in the field of medical devices. KEMA is notified body for active implantable -, in vitro diagnostic – and general medical devices. I initiated the business activities in Europe, USA, Israel and Japanand actively participates in the Notified Bodies meetings in Brussels.
I have lectured at numerous seminars and trainings in Europe, Israel, Asia and the USA. I am active for several years as a speaker and session leader at the annual RAPS conference in USA.
From 2004 until the end of 2007 I was executive director with Qserve consultancy in Amsterdam.
In 2008 I started my own consultancy company.
Since January 2010 I am a non-executive member of the board of directors of Obelis in Brussels.
I am also senior consultant and member of the advisory board of MDProject.
I participate in the Dutch standardisation body NEN in the advisory board on medical technology and in the working group for clinical evaluation. My expertise is with active devices.