Certificates and Compliance
At Seven Eight Sirgikal, we prioritize adherence to stringent quality standards and regulatory requirements to ensure the safety and reliability of our products. Our commitment to excellence is reflected in the certifications and compliance measures we uphold.
Medical Device Directive (745/2017) Compliance
We are proud to be fully compliant with the latest Medical Device Directive (745/2017), which sets forth rigorous standards for the manufacture and distribution of medical devices within the European Union. Our adherence to these regulations underscores our dedication to providing instruments of the highest quality and safety.
Notified Body Certification
Our products undergo thorough evaluation and certification by notified bodies, independent organizations authorized by regulatory authorities to assess compliance with applicable regulations. This certification provides assurance to our customers that our instruments meet the strictest quality and safety standards.
EUDAMED Registration
As a testament to our commitment to transparency and regulatory compliance, we are registered in the European Databank on Medical Devices (EUDAMED) with the assigned SRN # PK-MF-000009959. This registration ensures that our products are traceable and meet the necessary regulatory requirements for distribution within the European market.
ISO Certification
In addition to regulatory compliance, we maintain ISO certification to further demonstrate our commitment to quality management systems. Our adherence to ISO standards reaffirms our dedication to continuous improvement and customer satisfaction.
Quality Assurance
Quality assurance is at the core of everything we do. From the selection of raw materials to the manufacturing process and final inspection, we implement stringent quality control measures to ensure that every instrument leaving our facility meets our high standards of excellence.