Our pen passes rigorous dosing accuracy tests. According to certified results, our dosing accuracy falls well within the ISO-11608 standard range. Moreover, our pens pass dosing accuracy tests after exposure to stress tests:
Pooyesh Injection has implemented ISO 13485:2016 including the risk management approaches for quality management. The important objectives of ISO 13485 include the following aspects:
SO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
National Medical Device Directorate is responsible for monitoring and evaluating the authenticity, quality, and safety of medical, dental, and laboratory devices and licensing the applicants for various actions and processes in production, import, export, distribution, supply, and after-sales services.
Pooyesh Injection is in the process of audition by IMED for manufacturing injection systems for insulin pens
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
The injector pens manufactured by Pooyesh Injection comply with all requirments described in ISO 11608-1:2014