ORCL Medical has obtained several important quality certifications that demonstrate its commitment to high standards and regulatory compliance in the medical device industry:
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EU TUV South German ISO 13485 Quality Management System Certification
This certification confirms that ORCL Medical's quality management system meets the stringent requirements for the design, development, production, and servicing of medical devices, ensuring product safety and reliability. -
EU CE (0123) Certification
The CE certification indicates that ORCL Medical's products comply with the essential requirements of relevant European Union directives and regulations, allowing them to be marketed and sold within the EU. -
China NMPA (formerly CFDA) Medical Device Registration Certificate
This certification ensures that ORCL Medical's products meet the regulatory standards set by the National Medical Products Administration of China, allowing them to be legally marketed and used in China. -
China National High-tech Enterprise Certification
This certification recognizes ORCL Medical as a high-tech enterprise, highlighting its innovative capabilities and technological advancements in the medical device field.
