MDSAP Annual Aduit-2025

From February 25th to 27th, 2025, the MDSAP annual audit was successfully conducted at Omni Factory. The assessor visited and performed a comprehensive review of the Quality Department, Production Department, After-sales Technology Department, Sales Department, Purchasing Department, and Warehouse.

Content

The 2025 MDSAP audit focused on updates to the MDSAP system, including the addition of new products such as microneedles and new models of diode lasers. The audit also included a sampling check on design and development processes, as well as the intended use scope of new products. Key areas reviewed included production control, microneedle production, batch production records, equipment maintenance, sales services, procurement evaluation, supplier quality management, and external expert collaboration.

Specialist advise

The auditor highlighted two main areas for improvement:

1. Compliance with U.S. Regulations: Due to the company’s participation in a U.S. exhibition this year, the auditor emphasized the need to comply with local sales regulations and necessary legal procedures.

2. Disinfection Guidelines for Microneedles: For the new manual microneedle product, standardized disinfection guidelines must be established to ensure consumer safety during use.

Result

For new product applications, agents are requested to refer to the results of subsequent releases on our official website. The auditor commended our rigorous approach to quality management, well-documented procedures, and continuous improvement efforts. They also acknowledged our team’s prompt and effective resolution of minor non-conformities identified during the previous year’s audit. This achievement reflects our ongoing commitment to upholding the highest quality standards in product development, manufacturing, and distribution.

Action Plan

• The R&D department will continue refining troubleshooting guidance for each product series.

• For the new microneedle product, standardized disinfection guidelines will be developed and implemented to ensure safe usage.

• The Sales Department will strengthen after-sales support by providing comprehensive training to customers on the proper use. Additionally, a dedicated customer service team will be established to address inquiries and feedback promptly, ensuring a high level of customer satisfaction.

Looking Ahead
Omni Laser remains dedicated to maintaining the MDSAP medical management system, ensuring reliable certification, and meeting regulatory requirements for new products. We will address the identified advice and continue to improve our processes to deliver safe and effective medical devices to the global market. The MDSAP annual audit plays a vital role in maintaining compliance, enhancing product quality, and building trust with our stakeholders. Our mission to provide high-quality medical devices remains at the core of everything we do.

By Luna