Dr. Hans-Joachim Graf has been active in the health sciences sector for over 35 years. Since 2003, he has been managing the companies of the qtec group and supports clients worldwide as a qtec expert on regulatory topics such as the successful conformity assessment and market approval of medical devices and in vitro diagnostic medical devices (IVDs).
As a trainer, Dr. Graf teaches for the qtec Academy, Medical Mountains, and other training providers, instructing medical device manufacturers on a wide range of topics in the medical device field. His main areas of expertise include process validation, statistical methods, Design of Experiments (DoE), and trend reporting in accordance with Article 88 of the MDR.
What matters most to him as a speaker: "In my training courses, the focus is not on the formal aspects of regulatory requirements, but on their practical implementation. For me, ensuring the safety and functionality of a medical device is more important than generating piles of documentation out of fear of the next audit."
