MDSAP Annual Review: Results and Feedback

MDSAP Annual Review: Results and Feedback

29 January 2026

MDSAP Annual Audit – 2026

From January 27th to 29th, 2026, the annual MDSAP audit was successfully conducted at Omni Factory. During the audit, the assessor carried out a comprehensive on-site review covering the Quality Department, Production Department, R&D Department, After-sales Technical Support, Sales Department, Purchasing Department, and Warehouse, ensuring full compliance with the MDSAP medical device management system.

MDSAP Annual Review: Scope and Focus

The 2026 MDSAP audit focused on the continued implementation and effectiveness of the MDSAP system, with particular attention to:

• Ongoing compliance with regulatory requirements across different target markets

• Updates and maintenance of quality management documentation

• Design and development controls for existing and newly optimized product models

• Production process control and batch production records

• Equipment calibration and preventive maintenance

• Supplier evaluation and procurement quality management

• After-sales service processes and customer feedback handling

The auditor also conducted sampling inspections on design change records, risk management files, and production traceability to verify system consistency and execution.

Auditor Feedback and Recommendations

The auditor provided positive feedback on the overall operation of Omni Laser’s quality management system and highlighted the following key observations:

1. Regulatory Awareness and Market Compliance
   The auditor emphasized the importance of continuously monitoring regulatory updates in target markets to ensure that product promotion, sales activities, and documentation remain fully compliant with local regulations.

2. Process Optimization and Documentation Consistency
   While the system is operating effectively, the auditor recommended further strengthening cross-departmental coordination to ensure timely updates and consistency of records following product upgrades or process improvements.

Audit Result

The audit was successfully completed, and the auditor recognized Omni Laser’s stable system operation, clear documentation structure, and strong execution capability.
In particular, the auditor acknowledged the company’s effective implementation of corrective and preventive actions (CAPA) from previous audits, demonstrating continuous improvement and a proactive quality mindset.

For any new product or model applications, agents and partners are advised to refer to subsequent announcements published on our official website.

Action Plan

Following the auditor’s recommendations, Omni Laser will implement the following actions:

• The R&D Department will continue to optimize design documentation and troubleshooting guidelines to ensure alignment with regulatory and clinical requirements.

• The Quality Department will enhance internal audit and document review mechanisms to maintain consistency across departments.

• The Sales and After-sales Teams will further strengthen product usage training and customer support processes, ensuring accurate information delivery and improved user experience.

Looking Ahead

Omni Laser remains firmly committed to maintaining and continuously improving the MDSAP medical device management system. Through strict compliance, systematic management, and ongoing optimization, we aim to support the stable launch of new products and ensure their safety, effectiveness, and regulatory compliance in global markets.

The annual MDSAP audit continues to play a critical role in reinforcing product quality, regulatory confidence, and stakeholder trust. Delivering reliable, high-quality medical devices remains the core mission of Omni Laser.