Head of IVD and Principal Consultant
Entourage GmbH
Sven Hoffmann has an educational background in biotechnology engineering with >19 years work experience in the IVD sector and is a senior regulatory affairs executive.
He is the Head of IVD and Principal Consultant at Entourage GmbH, a Munich based consulting company in the Medical Device and Pharmaceutical area. Within RAPS, he is a member of the RAPS European Council (REC).
Before joining Entourage GmbH, Sven has worked for TÜV Rheinland for more than 15 years, a leading German Notified Body and Certification Body in the Medical Device / IVD sector. During his time at TÜV Rheinland he has held both, technical roles (e.g. Certification Officer, Lead Auditor and Technical Expert/Reviewer) as well as senior management positions (Global Head Business Segment IVD, Global Head Technical Competence Center IVD and department Head IVD Germany).
For his last 4 years with TÜV Rheinland , he was globally responsible for the entire IVD business segment, including certification services under IVDR, IVDD, EN ISO 13485 and MDSAP. In this role he also represented TÜV Rheinland in all relevant stakeholder meetings and working commitees for IVD related topics (e.g. TeamNB, MDCG mirror group, industry commitees with MedTech Europe or VDGH).
Previous to his TÜV Rheinland career, Sven Hoffmann started his professional career as Head Product Specialist at Abbott Diagnostics, gaining industry experience in the production of immunoassays for infectious diseases diagnostics.
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