sitem-insel AG

Mathias Eng

Mathias T. Eng, Founder & CEO of QUAREGIA GmbH, Founder & CEO of PROREGIA AG



Modules

Medical Device Regulatory Affairs and Quality Assurance:


Biography

Mathias T. Eng is an expert for quality management systems and medical device regulations. Since 2001, he is working with medical devices and combination products in general and medical device software embedded into devices or as standalone applications (SaMD) in particular. He has been working for clients in the medical device, pharmaceutical, biotechnology and diagnostic industries. Since 2007, Mathias is actively participating in building up, maintaining and teaching life science related modules for universities and other institutions.

Mathias T. Eng holds a master in computer science and a bachelor of science in civil and structural engineering. During his career, he worked for 4 years as an engineer for medical device software devleopment, 3 years as a project manager for developing medical devices, 4 years as a member of the IT-services team and 2 years as a leader of the IT-services team at CSA Engineering AG. For 11 years he worked as a senior consultant and partner at confinis ag.

In 2019 T. Eng founded QUAREGIA GmbH and in 2020 he founded PROREGIA AG. At QUAREGIA Mathias T. Eng provides quality management- and regulatory affairs services for medical devices, in-vitro diagnostic devices, combination products, medical device software, cybersecurity and artificial intelligence. While at PROREGIA he provides digitalization services for lifescience- and other industries such as (software) process automation, end to end cybersecurity concepts, cybersecurity platforms, cybersecurity verification and validation, cybersecurity post-market surveillance and professional services for developing and validating artificial intelligent systems.