sitem Center for Translational Medicine and Biomedical Entrepreneurship

Module 2 - Good Manufacturing Practice and Quality Management

Markus Wipf

CEO and Owner of Axxos GmbH

Modules

Translational Medicine and Biomedical Entrepreneurship

Module 2 - Good Manufacturing Practice and Quality Management

Medical Device Regulatory Affairs and Quality Assurance

Module 5 - Quality Management

Biography

Markus Wipf has has been working in the medical device area since 1995. Until 2005 he was with the former companies which were merged into Smith&Nephew Orthopedics Switzerland and was one of the forces who supported company growth from 35 employees in 1995 to 180 in 2005. In 2007 he founded Axxos GmbH with the target to provide quality management services to medical device companies.

Today, with Markus as CEO, Axxos GmbH provides quality management and conformity assessment services, has four certified auditors to perform both, internal and supplier audits according ISO or FDA requirements, compiles clinical evaluation reports and establishes technical files for the CE marking of medical devices.

He holds a MSc in mechanical engineering and additional Master degrees in economics and human resource management.