Maciej Dubowik

Maciej serves as a Regulatory Affairs Associate at Pure Clinical. He is responsible for projects related to the implementation of quality management systems in accordance with ISO 13485 and for conformity assessment of medical devices. His work includes the preparation of technical documentation and supporting clients in usability testing, risk analysis, and software validation for medical devices, including active devices and SaMD (Software as a Medical Device). He holds a Master’s degree in Acoustics and is a qualified hearing aid specialist. Maciej graduated from the Adam Mickiewicz University in Poznań, Faculty of Physics. He previously worked in the R&D department of a hearing aid manufacturer, where he was responsible for testing and verifying device prototypes in acoustic and electrical laboratories.