Chinese Medical Device Management System Regulations

We provide quality management system audit services – QMS – for medical device manufacturers. 

  • Manufacturing

  • Distribution

  • Sourcing – material, components, finished products

  • Clean room and sterilization operations

  • Active devices

  • Non-active devices

  • Sterile, single-use device

  • Other specialized products

Audit is: 
Systematic independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. 

Our bilingual auditors can audit in China and rest of the world, adhering to the principles of auditing: 

  • Integrity

  • Fair Presentation

  • Due Professional Care

  • Confidentiality

  • Independence

  • Evidence Based Approach

  • Risk Based Approach

Audit Criteria: 

  • ISO 13485:2016
  • Chinese Quality System Regulations on 
    • Manufacturing
    • Distribution
    • Post market
  • Gap Analysis
  • Surveillance / Maintenance Audit
Former US Deputy Attorney General Paul McNulty:

“If you think compliance is expensive, try non-compliance.”