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On site verification of quality management standards for medical device production


Release time:

2023-04-12

The two-day on-site quality system verification for type III products was successfully completed on the afternoon of April 12th. Four expert teachers from the audit team conducted a rigorous and meticulous inspection of type III products from Keenman, including non-absorbable suture anchors, fixed button, and adjustable button. From system documents to on-site dynamic inspections, the teachers provided professional review and guidance, and provided rectification suggestions and directions.

The two-day on-site quality system verification for type III products was successfully completed on the afternoon of April 12th. Four expert teachers from the audit team conducted a rigorous and meticulous inspection of type III products from Keenman, including non-absorbable suture anchors, fixed button, and adjustable button. From system documents to on-site dynamic inspections, the teachers provided professional review and guidance, and provided rectification suggestions and directions.

This verification has profound significance for Keenman. Keenman's quality system has undergone practical testing, and of course, it needs to be continuously optimized and improved according to the actual situation of the company in the future; In addition, it has also strengthened the company's strategic positioning of focusing on the development of minimally invasive orthopedic small joint innovative devices and implanted prostheses.

The verification further tested the cohesion of the team, and employees from various departments worked overtime before the verification to conduct self checks, fully demonstrating the spirit of ownership.

 

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