Cecilia has extensive experience from the medical device industry and from academic research. She has specific expertise in clinical evaluations, patient safety issues, clinical risk/benefit analyses, usability aspects and scientific reviews.
Cecilia holds a PhD and an MScPharm from Uppsala University, where she is also appointed associated professor.
“A clinical evaluation is required by the MDD for demonstration of conformity with the essential requirements. How do you recommend companies to handle this?” ”I recommend to start with the clinical evaluation already in the initial phases of product development. Early identification of the need for clinical data to ensure safety and performance of the device makes it possible to plan for clinical studies well in advance. In the long run, a well performed clinical evaluation saves time and money as well as enhances product quality.”