ISO 13485:2016 Certification (Quality Management System for Medical Devices)
This standard is specific to quality management in the manufacturing of medical devices and certifies that Bita Salamat Pariya consistently meets customer needs and regulatory requirements by implementing a robust quality management system.
This certification encompasses all processes related to the design, manufacturing, and sale of sterilized disposable medical equipment. One of the key aspects of this standard is ensuring full compliance with sterilization procedures, including ethylene oxide (EOG) sterilization, which plays a vital role in the safety of medical devices.
ISO 9001:2015 Certification (Quality Management System)
This standard is designed for quality management systems across various industries and demonstrates Bita Salamat Pariya’s commitment to delivering high-quality products that meet customer needs and regulatory requirements.
This standard refers to the production and sale of sterilized disposable medical devices and indicates that the company is capable of enhancing customer satisfaction through continuous improvement of operations and adherence to international standards.
Both of the above certifications are issued by the International Certification Authority (IGC) based in Seoul, South Korea, and demonstrate Bita Salamat Pariya’s commitment to adhering to international standards and quality.
Medical Device Manufacturing License from the Ministry of Health, Treatment, and Medical Education
Bita Salamat Pariya has obtained a medical device manufacturing license from the Ministry of Health, Treatment, and Medical Education of Iran, providing a valid certification for its activities in the production of disposable medical equipment. This license enables the company to manufacture and market its products in accordance with national and international standards.
This license certifies that all processes of design, manufacturing, and quality control at the company are conducted with precision and in compliance with health and safety requirements. The Ministry of Health, as the responsible authority overseeing the production and distribution of medical devices in Iran, has conducted a comprehensive review of all production stages and product evaluations to issue this license.
Obtaining this license not only demonstrates the company’s adherence to principles of quality and safety in the production of medical devices but also builds trust with customers and business partners, emphasizing the company’s commitment to enhancing community health.