Concept

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 MDD and IVDD.

 

mi-CE consultancy is expert in Quality Management System set-up to be in compliance with the requirements of ISO 13485:2003, ISO 9001:2008 and ISO 13485:2003 under CMDCAS (Canadian) and for Taiwan.

 

mi-CE consultancy also performs CE/QMS compliance audits and design dossier/technical dossier reviews for notified bodies.

 

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