SME Profile

Jan-Paul Van Loon

Jan-Paul is senior consultant International Regulatory Affairs with Qserve Consultancy BV. Prior to holding this position, he was Chief Technology Officer for a medical device company developing and manufacturing Class III heart assist devices as well as co-founder and Chief Operating Officer of a medical device start-up company. Jan-Paul is highly experienced throughout the medical device process from start to market introduction, including setting up an ISO 13485 quality system and CE and FDA mark submissions e.g. technical files, performing risk based validations, submitting international clinical trials and writing clinical evaluations. He holds a Master’s degree in biomedical engineering and a PhD in medical sciences. As co-author of more than twenty scientific articles and co-inventor of three patented inventions, Jan-Paul is also secretary of the biomedical department of the Royal Dutch Society of Engineers.