Gustav Hoppe

Gustav Hoppe is a Senior Regulatory Affairs and Quality Assurance Consultant at PlantVision AB, specializing in regulatory strategy for medical devices and IVD instruments, with extensive experience in technical file preparation and FDA submissions. Previously, Gustav served as a QA/RA Specialist at RaySearch Laboratories, focusing on software as a medical device for radiation therapy. In a significant tenure at UL, Gustav held roles including Staff Engineer and Senior Project Engineer, managing safety compliance evaluations for medical devices and being a regional technical lead for usability standards. Earlier career highlights include a position as a Regulatory Affairs Specialist at MASIMO Sweden AB, overseeing international certifications, and R&D roles at Sigma Design and Development, specializing in embedded software for medical solutions. Academic qualifications include a Master of Science in Engineering Physics and a Bachelor of Science in Electronics and Computers from Umeå University.