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TUVHD provides audit, certification, and training services for multiple fields, as well as product testing services

Medical industry

The medical industry is an important field related to the national economy and people's livelihood, which includes medical services, drug production, medical device manufacturing, health insurance, biotechnology research, and health management. The industry aims to ensure and improve the health level of the people, providing disease prevention, diagnosis, treatment, and rehabilitation services through institutions such as hospitals, clinics, and pharmacies. The medical industry is not only directly related to everyone's life safety and quality of life, but also a key force in promoting social and economic development and technological progress. With the continuous innovation of medical technology and the popularization of health concepts, the medical industry is developing towards a more specialized, refined, and intelligent direction.

Medical industry certification is crucial, ensuring the quality of medical institutions, personnel, products, and services, and is also the key to entering the market. Medical device certification ensures product safety and compliance, enhances consumer confidence and promotes healthy industry development, reduces counterfeit products, and promotes international trade. At the same time, third-party certifications such as ISO9001 verify the technical compliance of products, services, and management systems, providing quality assurance for consumers and helping medical institutions maintain high standards of management. These certifications jointly promote the quality improvement and sustainable development of the medical industry.

Introduction to main certification projects:

ISO 13485 certification: This is an internationally recognized quality management system standard specifically designed for the medical device industry. It emphasizes the quality management system requirements for the design, development, production, installation, and service of medical devices. Applicable to medical device manufacturers, suppliers, and service providers.
ISO 9001 certification: Although ISO 9001 is not specifically designed for the healthcare industry, it is a widely used quality management system standard that many healthcare organizations also adopt to enhance overall quality management. Suitable for various types of organizations, including healthcare providers.
Environmental management system certification (such as ISO 14001): Although not specifically aimed at the healthcare industry, it helps healthcare institutions demonstrate their commitment to environmental protection.
Occupational health and safety management system certification (such as ISO 45001): applicable to all industries, including the medical industry, focusing on workplace health and safety.

Reference application certification project

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    ISO13485 Medical devices quality management systems

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