Erika Lokander
IVDR - Affiliated Consultant
Erika Lokander has over 20 years of global regulatory and quality experience in the medical device, IVD, and pharmaceutical industries, with a focus on SaMD and AI/ML-based technologies. She has held leadership roles at start-ups and multinational companies, including TÜV SÜD, Asuragen, Smith & Nephew, ArthroCare, IDL Biotech, Knightec, and AstraZeneca.
She has led regulatory strategies and submissions in 90+ markets worldwide, including FDA (PMA, De Novo, 510(k)), CE-marking, and MDR/IVDR transitions, covering all device classifications. Her expertise spans quality assurance, project management, and cross-functional team leadership, guiding products from early development through global approvals and commercialization.
Her portfolio includes orthopedic, cardiovascular, diagnostic, and software-driven devices, as well as advanced IVDs in oncology, genetics, and infectious diseases. She holds a Bachelor’s Degree in Biotechnology/Biochemistry from Mälardalen University and is currently completing her Executive MBA at the University of Colorado.
