In March 2016, the new version of ISO13485 quality management system for medical devices was officially implemented. Correspondingly, the relevant laws and regulations for medical devices also have further regulatory requirements. This change obviously can further standardize the production of medical equipment enterprises.

 

 

In order to implement the requirements of the system and relevant laws and regulations, and put the production management and product quality standards into practice, recently, jho carried out training on product standards and practical laws and regulations.

 

 

Last month, JH went to Guangzhou to participate in the training course of ISO13485 standard and relevant laws and regulations. The internal training of JH is to convey the deepening content to the middle-level management, and the course is assessed in the form of face-to-face examination.

The requirements of quality management system and laws and regulations, compared with the past, are more clear about the requirements and responsibilities of enterprises in production and management, more specific guidance on how to conduct standardized operation, and certainly more strict. Strict means that the threshold is high, while the entry threshold in the field of medical devices is already high; the strict requirements and approval for class I, II and III medical device products and manufacturing enterprises are the last threshold in the field, but before that, enterprises should first check it.

 

 

Only when we have strict requirements for ourselves and strict control over our products, and every detail and every product is full of care, can we truly serve our customers' health with "excellent medical equipment enterprises".