Technical File Assistance
This service can be provided upon request by Obelis Senior Regulatory Expert Dr. Peter Ruys.
Dr. Ruys is an expert consultant in International Medical Device regulations. He is the founder of the Notified Body KEMA Quality in The Netherlands (1992-2004) and was involved in the initial implementation of the European Directives for Medical Devices. He holds degrees in physics and chemistry from the University of Utrecht. Dr. Ruys served many years as a Certification Manager for medical devices, was executive director with Qserve consultancy (2004-2008) and recently launched his own consultancy company. He acts as Senior Regulatory Expert for Obelis s.a.
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Please visit the Obelis Fast Lane for more information.