Joana holds a master’s degree in biomedical engineering from DTU and a bachelor’s degree in the same field from the University of Lisbon. With her previous work experience at Coloplast, Joana has acquired vast knowledge within risk management activities and design control processes for class I to III medical devices. Joana’s work was to ensure that the documentation package of legacy products was in compliance with MDR. This included ensuring that the design input requirements met the user’s needs as well as regulatory requirements, while keeping the risk to the user as low as possible. Joana also worked on bridging documentation related to the usability of legacy devices with the risk management files. As a Design Control Specialist, she is pragmatic and a fast learner, and she thrives working independently or in a team.