Magdalena Heine has several years of experience in medical device development and combines her technical expertise with regulatory know-how as a qtec expert.
Specializing in regulatory requirements for software development, she has served as Person Responsible for Regulatory Compliance (PRRC) and risk manager for standalone software products. As a Product Owner, she also has in-depth knowledge of agile methodologies and product development processes.
Her previous work as a paramedic provides her with a hands-on, practical perspective on the use of medical devices in clinical settings. Magdalena supports companies not only in software and product development, but also in the digital transformation of regulatory processes. Her practical approach and broad expertise make her a sought-after speaker and consultant in medical device development.
As a trainer at the qtec Academy, she focuses on medical device software development and the digitalization of regulatory processes.
What matters most to her as a speaker: "I’m passionate about sharing my experience and knowledge to drive innovation together with participants and to improve the quality of medical devices."
