Albert Roossien

Bert holds a MSc degree in Medical Biology and a PhD Degree from the Medical Department of the University of Groningen, The Netherlands. He has 20+ years of experience in the Medical Device Industry (Cordis [a Johnson & Johnson Company], PendraCare and Wellinq). As a Quality & Regulatory Manager,  Bert was responsible for the Regulatory input in the Product Development of Vascular Products, the Quality Assurance Aspects within Product Development (R&D) and Quality Controls within the Operations and the maintenance of the Quality Management System. In 2017, Bert joined BSI as a Regulatory Lead. He was involved in the initial designations of BSI as a Medical Devices Notified Body for the European Council Directives (MDD, AIMDD, IVDD) and European Medical Devices Regulations (MDR and IVDR). Within BSI, he is involved in the maintenance of the MDR / IVDR designations. He is also involved in the maintenance of BSI’s Quality Management System Processes (approval of procedures). Furthermore, he conducts competence verifications and authorizations to BSI employees. Bert participated in the development of BSI’s Article 16(4) Certification Scheme.