Maiken Worsøe Rosenstierne

Maiken holds a Bachelor’s and master’s degree in Biochemistry and a PhD in Molecular and Cellular biology – all from the University of Copenhagen. After graduating as PhD in 2005, she had a couple of post doc positions at the University of Copenhagen followed by a position as Senior Scientist at Statens Serum Institute, before finding her way into medical devices. Since 2020, she has worked within IVDR medical device development in a Danish startup first as Head of Assay development and then as Director of R&D where she was responsible for new product development under the IVDR transition. Working in the startup environment has strengthened her ability to deliver quality results in a fast-paced and agile setting and given her hands-on experience in product development. She has developed skills within a broad range of disciplines in product development such as user studies, concept development and design processes including IVD Medical device development such as, IVDR compliance, project management, design control, product labelling, test method development, analytical performance evaluation and clinical validation. Now, as a Design Control Specialist, she combines her analytical skills with the ability to break down complex problems/projects into manageable tasks to support teams in achieving their goals.