Certificates

Those who want to manufacture medical devices in Iran have to get an approval by the Ministry of Health. Good Manufacturing Practices (GMP) and applying safety regulations are preconditions for obtaining this manufacturing license. The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. Further standards are IEC 60601-1, for electrical devices (mains-powered as well as battery powered) and IEC 62304. Piyavar has succeeded to obtain ISO 13485:2003 and ISO 9001:2008 standards. The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers and other stakeholders. ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives. The letters "CE" stand for "Conformité Européenne" ("European Conformity"). Piyavar affixes all its products with CE mark.
Dear partners, please be noted that our ISO 13485 certificate issued by BSI is not in effect from December the 10th 2012. We are renewing our ISO 13485 with another group.

Certificates

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  • Awards & certificates