Thorsten Schmitt is Managing Director of the NEMIUS Group, based in Mainz, Germany. He has more than 15 years of experience in regulatory and quality affairs for medical devices, combining practical knowledge from over 500 projects in medical technology with academic expertise gained in Frankfurt, Lübeck and Boston (MIT).

He specialises in helping companies navigate complex regulatory frameworks such as MDR, IVDR, and FDA requirements. His consulting services focus on CE marking, FDA submissions, biocompatibility, sterility, quality management systems (ISO 13485, MDR, MDSAP, GMP, ...) and audit preparation.

Thorsten is also known for his strategic clarity and ability to simplify regulatory pathways. He supports start-ups and established medtech companies alike – from early development to successful market entry in Europe and the US.