QMS

The establishment of quality system is the necessary basis for medical equipment access. There are differences in the quality system standards / regulations implemented by different competent authorities.

ISO 13485 Certification is the most common approach and a basic requirement for a firm to demonstrate QMS compliance in EU, Canada, Japan, Australia and other regions .

In China, NMPA issued China Good Manufacturing Practice for Medical Device (trial) (hereinafter referred as GMP). The GMP is the basic principle for medical device manufacturing and quality management system, which is applicable to design development, production, distribution and servicing of medical devices .Therefore, medical device manufacturers shall establish quality management system and keep it effectively per GMP.

In U.S, FDA has issued 21 CFR Part 820. Medical device manufacturers are required to pass the on-site inspection by FDA, especially for overseas importers.

In Brazil, ANVISA has issued RDC 16/2013 Brazil Good Manufacturing Practices (BGMP). Medical device manufacturers are required to pass the on-site inspection by ANVISA prior to Registro Submissions .

We can provide integrated services. including gap analysis review, quality management system

establishment, internal audit. mock audit and gap closure.

◆ISO 13485: 2016/ EN ISO 13485:2016 & YY/T 0287:2017

◆BGMP RDC 16/2013

◆CAN / CSA ISO 13485

◆ 21 CFR Part 820