MDSAP Annual Aduit-2024

From April 17th to 19th, 2024,the MDSAP annual review conducted successfully at Omni factory. The assessor from Intertek Group visited and conducted a very strict review of the Quality Depart,Production,Depart,After-sales Technology Depart, Sales Depart, Purchasing Depart,and Warehouse. 

Content

The MDSAP audit encompassed various aspects of our operations, including quality management systems, risk management, product design, supply management, , and more. Among these ,the data qualified products and mass production records are emphasized.

Result

We have successfully passed the MDSAP annual review, which is an affirmation of our commitment to ensuring the highest quality standards in our product development, manufacturing, and distribution processes. We take pride in this achievement as it reinforces our dedication to providing safe and effective medical devices to our customers worldwide.

The auditor provided valuable feedback, commending our strict attitude towards quality, well-documented procedures, and the continuous improvement efforts displayed across all levels in our organization.And also acknowledged our team's promptness and effectiveness in addressing any minor non-conformities identified after last year’s audit. Action

• The R&D department needs to continue to refine trouble shooting guidance for each series of products.
• Q-Switch Nd: YAG Laser requires additional biocompatibility testing

Looking ahead, Omni Laser will continue to maintain the MDSAP medical management system, continue to bring reliable certification and legal supervision of new products on the existing basis, and improving current shortcomings. We understand the importance of this annual review in maintaining compliance, improving product quality, and building trust with our stakeholders. After all, our mission is to deliver safe and effective medical devices to the market, and the MDSAP plays a crucial role in that journey.