Quality System Consulting

A good quality management system is not only the requirements of premarketing and post-marketing, but also brought the advances for our clients in the fierce market competition.

Our consulting team provide following consulting service of quality management system, including establishmen, internal audition, mock audition, gap analysis and gap closure of QMS.

ISO 13485 / ISO 15378 of the EU.

China Manufacturing and Quality Practice for Medical Devices.

U.S. FDA 21 CFR 820 Quality System Regulation.

RDC16/2013 Good Manufacturing Practice of Brazil.

Medical Device Single Audit Program (MDSAP) accepted by

multiple countries.