Ittipan Kanluan, Dipl.-Ing., is a Regulatory Affairs Expert in the field of Active Medical Devices / Medical Software at CE plus GmbH, an international service provider for medical devices and in vitro diagnostics based in Germany.
He has over 6-year experience in the medical device industry. After graduating with a Dipl.-Ing. in Electrical Engineering and Information Technology from Karlsruhe Institute of Technology (KIT), Germany, he worked as a software engineer with a medical device manufacturer. He was responsible for developing software components for a high-risk medical device. He gained in-depth experience in product development, software life-cycle process, requirements engineering, risk management, and technology implementation.
At CE plus, he is responsible for Active Medical Devices and Medical Software. He provides consulting to clients in regulatory process for CE-marking in compliance with EU Directives 93/42/EEC. He assists medical device manufacturers in product classification, selection of suitable procedures for conformity assessment, gap analysis, and Technical Documentation compilation. Furthermore, he also supports clients in the software life-cycle process according to IEC 62304, risk management according to EN ISO 14971, usability engineering according to IEC 62366, and requirements engineering.
Ittipan is a member of the VDI expert committee for quality assurance for medical software.