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We Passed CE Unannounced Inspection and Version Upgrade Certification

2018-09-10

On September 7, 2018, BSI visited us for unannounced inspection. The Audit Team audited the management review, internal audit, design & development, quality control, production management, data analysis, post-market clinical follow-up, adverse event monitoring, risk management and quality inspection procedures respectively by reports of relevant personnel, spot inspection and records review. This audit was conducted for the dental desensitizer and bio-degradable hemostatic material. We earned recognition from the Audit Team for excellent product process and rigorous GMP flow and successfully passed the unannounced inspection.

During September 13 through 14, 2018, BSI carried out audit for version upgrade certification. The Audit Team audited the institution and personnel, premises, equipment, document management, design & development, procurement, production management, quality control, sales and after sales services, adverse event monitoring, post-market clinical follow-up, risk management, etc. respectively by reports of relevant personnel, on-site process check and records review. This audit was conducted for the dental desensitizer and bio-degradable hemostatic material. We successfully passed the certification with our joint efforts.

Defects in our quality management system were pointed out during the CE unannounced inspection and version upgrade certification, which could help the continuous improvement of the system to produce safety and effective products. Our products will be exported to international markets through CE certification and we will make our way on the international stage faster and further.