Hedvig Tuxen-Meyer Senior Quality and Regulatory Consultant
Hedvig has 30+ years of experience from working with medical devices and other life science products, including product development, quality assurance and process improvements. Hedvig is appreciated for her deep knowledge, thoroughness, analytical mind and amiability. She has specific competence in requirements design and analysis, risk analysis and verification/validation in accordance with MDD and QSR.
Hedvig holds an MSc Engineering Physics from the Royal Institute of Technology in Stockholm and is a certified Requirements Analyst (REQB) and certified SW Tester (ISTQB).
“Many companies struggle with getting their medical device on the market, which requires fulfillment of many regulations and standards. How do you recommend MedTech companies to handle this?” ”Classify your product early during the development to define what is needed to fulfill the regulations. This has big impact on the whole project; the level of documentation, verification, validation, risk analysis etc.”