Founder l Qserve Group Europe, USA, China & Hongkong
He brings more than 25 years of senior management skills to the Qserve Group in the areas of Quality Management Systems and International Regulatory Affairs.
He is a qualified (Mock) Lead Auditor holding Notified Body certification and CMDCAS certification. Willibrord’s particular fields of expertise are strategy & planning development, international quality management systems e.g. ISO 13485, FDA Quality Systems Regulations (QSR) 21 CFR Part 820, Canadian CMDCAS, ISO 9001, Medical technology and auditing.
Willibrord has extensive knowledge of international Medical device regulatory affairs and has specialist knowledge of CE Marking and 510(k).
He is also an experienced coach of senior managers and is a qualified trainer in all aspects of quality management systems, auditing, and regulatory affairs.