Possible Reduction on Medical Device Accidents

Quality status of current medical devices in Hong Kong

The committee of Hospital Authority (HA) Hong Kong believes that the government’s buildings and facilities are old, and more than half of them have been completed for more than 30 years; coupled with the continuous increase in the demand for hospital services, the use of medical equipment and facilities has remained extremely high for a long time. Recently, the committee put forward a number of recommendations on strengthening the maintenance of medical devices, equipment.

Taking Appropriate Action

The quality of medical device manufacturing and management not only affects the industry itself, but also has a direct impact on stakeholders such as medical staff and patients. The international standard setting of ISO 13485 therefore ensures that organizations can improve efficiency, cut costs and monitor supply chain performance to demonstrate that the medical devices they produce are safer and more effective.

About ISO 13485

The international standard ISO 13485 forms the basis for the certification of the quality management system of companies that manufacture or distribute medical devices or participate in their manufacture as part of the supply chain.

In terms of content, it sets out the requirements that medical device manufacturers and suppliers must meet when developing, implementing and maintaining a management system for the medical device industry.

Through ISO 13485 certification, organizations can increase access to more markets around the world and meet regulatory requirements and customer expectations.

Relevant Services by DQS

• DQS provides ISO 13485 Certification, MDSAP Medical Device Single Audit Program (MDSAP), and CE Marking against Regulation (EU) 2017/745 (MDR) services. 
• DQS Academy provides training courses to help customers understand the standards.