Robin Barwegen

Robin Barwegen has worked in the Quality Assurance and Regulatory Affairs field since 2012. From 2012-2013, Robin was an intern at Toll Collect, where they completed a master's thesis. From 2013-2018, Robin was a Manager of Quality Assurance and Regulatory Affairs at Inreda Diabetic, where they were responsible for maintaining the certification of the QMS according to ISO 13485:2012 & MDD 93/42/EEC, updating the QMS according to ISO 13485:2016 & MDR 2017/745, conducting internal and external audits, coordinating the process for obtaining CE marking, developing and maintaining the technical file of the artificial pancreas system, and advising the organization regarding new regulatory requirements. From 2018-2022, Robin was a Senior Consultant of QA/RA at MDProject, where they were responsible for supporting clients with mainly active medical devices including software or firmware, such as support with qualification of Medical Device Software under MDR 2017/745 and IVDR 2017/746, support with implementation of a Quality Management System based on ISO 13485 and IEC 62304, support with creation of the Technical Documentation based on MDR 2017/45 and IVDR 2017/746, support with implementation of various standards such as IEC 60601-1, ISO 14971 and IEC 62366-1, support with clinical evaluation based on MDR 2017/745 and MEDDEV 2. 7/1, providing training on IEC 62304, IEC 82304-1 and MDR 2017/745 software specifics, support with regulatory submission and contact with Notified Body, and performing internal and supplier audits. Robin is currently the Head of QA/RA at ScreenPoint Medical.

Robin Barwegen obtained a Bachelor of Science (BSc) in Business Administration from the University of Twente between 2007 and 2011. Robin then went on to pursue a Master of Science (MSc) in Business Administration from the same university between 2011 and 2013. Additionally, they obtained a Master of Science (MSc) in Innovation Management & Entrepreneurship (IME) from the Technische Universität Berlin between 2011 and 2013. In 2017, they obtained a RAC (EU) certification from the Regulatory Affairs Professionals Society (RAPS).