Emma Axelsson
Senior Quality and Regulatory Consultant

Emma has many years of experience in the quality and regulatory area within the medical device and IVD industry. Emma has hands-on experience of medical device development, from innovation phase to a CE-marked device, and she has contributed in a large variety of projects including quality management system implementation, technical file preparation, regulatory submissions, testing and verification, usability, labeling and risk management.
Emma is perceived as effective and swift when handling tasks. Quality, deep knowledge and communications skills are some of the qualities that describe her well in her profession. She is a skilled and appreciated trainer of our MDR and IVDR courses.
Emma holds a MSc in Biotechnology from University of Linköping.

“What is your best advice to a newly appointed Quality and Regulatory Manager?”
”Work risk based and use the full potential of it to focus your efforts to where they are best used. Set up your purchase routines, incoming inspections, process validations and more, develop your processes to suit the way you work, to help you deliver quality more efficiently, all with a risk based approach.”