Re-Meeting FDA Requirements to Produce Rooyagen PRP Kit

Re-Meeting FDA Requirements to Produce Rooyagen PRP Kit

Specialists and basic scientists of Rooyagen in Aria Mabna TashKhis Co. using European and American medical grade raw materials while obtaining various internal licenses (health reference laboratory, injection confirmation of Pasteur Institute of Iran, …) The first Iranian kit Is that all international standards for the production of PRP kits such as:

• 93 EC93 / 42 (Essential requirements for medical devices)
• ISO 9001: 2015 Quality management system
• ISO 13485: 2016, Medical devices Quality management system
• ISO 14971 Safety of medical devices
• ISO 10993 (1,3,4,5,7,10,11)

Has succeeded in re-meeting the requirements of the US Food and Drug Administration (FDA) in obtaining cGMP system management standards (FDA QSR 21 CFR 820) in the production of PRP kits by 2025.

  Finally, according to clinical results, published articles and scientific citation that have led to the widespread acceptance of this product in the country are also exported to foreign markets. Congratulations to the manufacturers of knowledge-based medical equipment and the scientific and medical community of the country for achieving these successes, and we sincerely thank all those who have worked hard in this difficult way to produce products with internationally accepted standards.

Best regards

Rooyagen Scientific Group