Concept

mi-CE consultancy offers complete (including Clinical) consultancy services for medical device and in vitro diagnostic (IVD) manufacturers for CE marking compliances according to the MDR and IVDR.

mi-CE consultancy is expert in Quality Management System set-up to be in compliance with the requirements of ISO 13485:2016, 21 CFR 820, MDSAP ISO 13485 and  ISO 9001:2015

mi-CE consultancy also performs CE/QMS compliance audits for notified bodies.

Our Focus is on high quality, pragmatic approach, fast response and dedicated project leaders responsible for each customer.