Quality and Regulatory

We maintain an industry-wide reputation as a manufacturer of high quality standards by planning, implementing and controlling projects in accordance with key standards, regulations and quality systems.

Quality Policy

• Focus on technology

• Strict on quality

• Benefit human health

Medical Device Registration

We have established a complete quality management system based on ISO 13485 and obtained the ISO 13485 certificate. We are currently working with an experienced notified body to prepare and submit the necessary documents to support EU regulatory approval; we have completed FDA factory registration and obtained the CFG certificate.

• Medical Device Registration

Regulation (EU) 2017/745

CFR Title 21

• Regulatory Reporting

Complaint handling & reporting

Investigation of complaints of adverse events

• Regulatory Vigilance

Post-market surveillance & trending

Periodic security update reports

Vigilance to ensure coordinated & timely corrective action

• Quality Management System

ISO 13485:2016 certified and undergo a stringent audit process

We will continue to conduct honest and fair business practices based on strict compliance with laws and corporate ethics to maintain our position as an ethical medical device company.