With more than 25 years of experience in medical device development, especially centered around user safety and risk management, Søren is a natural pivoting point when it comes to risk management according to ISO 14971. In addition, he has broad experience in quality management, systems engineering, design control, usability, labeling, manufacturing, complaints handling and post-market surveillance. Søren holds a Bachelor of Science in Electrical Engineering from Odense Teknikum in year 1985 and an additional Business education from Ålborg University in year 1993. With a strong analytical and structured mindset he can help MedTech companies with establishing a Risk Management Process and Risk Management Product Files, as well as solving non-compliance issues related to existing Risk Management processes and documentation.