at Medical Device Bureau

Assessment of quality, safety, and effectiveness of biomaterials (Bone Grafts, Bio Active Glasses, Blood Bags, Lenses, Biological Dressings), expert in production process. (From January, 2010 until Now)

Main responsibilities in the above posts were split between :

1. Assessment of quality, safety, and effectiveness of devices which are imported to Iran and giving import approval. In this case, duties include assessment of devices according to CE and European directive on medical device (93/42/EEC) as well as, US medical device regulation in this regard. Besides, these duties include assessment of the medical device price for governmental medical centers.

2. Assessment of quality, safety, and effectiveness of devices which are produces in Iran and giving production approval. In this case, duties include review of technical documentations including risk analysis, clinical investigation date and post market surveillance information. Medical device regulations in Iran stems from Global Harmonization Task Force (GHTF) suggestions which are deeply rooted in European regulations.

Iranian Medical Devices Directive, an introduction to Risk Management, Labeling Regulation of Medical Devices, an introduction to Quality Management System (ISO 13485), Essential Requirements of Medical Devices, an introduction to Good Manufacturing Practices (GMP), an introduction to EC Medical Devices Directive 93/42/EEC, an introduction to Clinical Data, Medical Devices Sterilization standards, an introduction to US Regulation for Medical Devices (FDA), an introduction to Post Market Services, an introduction to Biocompatibility Standards (ISO 10993).

Ceramic Manufacturing Process І, ІІ, ІІІ and Laboratories, Polymer Science and Technology, Method of Material Identification and Analysis, Ceramic, Computer Application in Ceramic, Metallographic Lab, Powder Metallurgy, Transfer of Technical & Scientific Subjects, Crystallography