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Possible Reduction on Medical Device Accidents
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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.
Author
DQS Hong Kong
DQS – Leveraging Quality, Driving Success.
DQS empowers organizations worldwide to build trust, drive innovation, and achieve sustainable growth by certifying the future of business. Founded in 1985, DQS has grown into a global leader in the assessment and certification of management systems, with a team of 3,000 highly qualified auditors delivering over 130,000 audit days per year in more than 60 countries. Through internationally recognized certifications across 200+ standards, DQS helps businesses manage risks, ensure compliance, and unlock new opportunities in an evolving regulatory and business landscape.
Thinking beyond compliance, DQS is a trusted partner for digitalization, automation, and sustainability leadership. The company’s expertise covers a wide range of areas, spanning from cybersecurity and AI governance to ESG compliance, supply chain management, medical device safety, and future mobility, delivering real value to industries in their pursuit of resilient, sustainable, and intelligent systems. By leveraging advanced auditing methodologies, predictive analytics, and real-time insights, DQS supports organizations to future-proof their operations while demonstrating their commitment to excellence and responsible business practices.
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