Exhilarating news! Majesty Achieves ISO 13485 Medical Devices Quality Management Systems Certification. On January 10, 2023, after an expert review, Majesty Packaging Systems Co., Ltd. passed the ISO 13485:2016 Medical Devices Quality Management Systems Certification. This certification covers the design and manufacture of medical irrigation heads and meets the requirements of the international standards organization for the quality management system.

The ISO certification affirms Majesty's management system and product quality to develop overseas medical devices with international pharmaceutical enterprises. Majesty is headquartered in Zhongshan, China, with a branch in Hong Kong, plants in Thailand and Brazil, with customers in over 40 countries. Furthermore, Majesty has obtained other certificates for packaging material and containers for Pharmaceutical use, ISO 9001, ISO 14001, and ISO 45001 system certifications.

The full name of ISO 13485 is Medical device-Quality management systems-Requirements for regulatory purposes. It is an independent international standard developed by the International Organization for Standardization (ISO) and applicable to the medical device industry. The current version of ISO 13485 is version 2016, which was officially released on March 1, 2016. This standard emphasizes the importance of implementing medical device regulations and ensures the safety and effectiveness of medical devices by meeting the requirements of medical device regulations. ISO 13485 certification reflects the construction of medical device enterprises' quality management systems must take safety and effectiveness as a principle, subject to legal constraints, and be legally compliance.