If you need free advice on obtaining ISO 13485, contact our advisors at Modirfa.
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ISO 13485 consultation
Modirfa is proud that after changing the version of the ISO 13485 standard, it has succeeded in implementing the ISO 13485 consultant and implementing this standard in a significant number of Iranian companies producing medical equipment.
Obtaining ISO 13485 certificate
Obtaining the ISO 13485 certificate is a requirement of the General Directorate of Medical Equipment of the Islamic Republic of Iran to obtain an activity license under the supervision of IMED, so all manufacturers and importers of medical equipment must implement ISO 13485 consultation and obtain ISO 13485 certification. ISO13485 certificate should be obtained from the list of CB certification companies trusted by IMED. This list is constantly changing, so it is recommended to consult with our advisors in the management of the ISO 13485 certification company to save your time and money significantly.
Advantages of ISO 13485 consulting
As one of the oldest and most established ISO 13485 consulting companies in Iran, and with the pride of providing ISO13485 consulting for many medical equipment manufacturers in Iran, we are ready to cooperate and provide ISO13485 consulting and obtain a valid certificate accepted by the honorable General Directorate of Equipment. Medicine as soon as possible and with the best management consulting methods.
One of the advantages of ISO13485 consulting in the organization is the implementation of the requirements of the quality management system in the organization because this standard has a lot of overlap with the ISO 9001 version 2015 standard, which helps to improve the quality management system in the organization as well as the level of customer satisfaction. . The new version of ISO13485 with the 2016 version provides suitable solutions in the direction of quality management, which is more useful for the organization than the certificate framed and installed in the organization.
Obtaining the ISO 13485 standard
Obtaining the ISO 13485 certificate is a necessary condition for obtaining a production and operation license from the General Directorate of Jumping Equipment of the Islamic Republic.
The cost of obtaining ISO13485
Obtaining the ISO13485 standard includes two main parts. The first part is related to consulting costs and the second part is related to audit costs. The audit costs depend on the type of CB selected to receive the certificate and the training costs by CB depend on many parameters, the most important of which are the number of personnel, the number of processes, the scope of work and the number of branches of the organization (head office, factories, sales branches, etc.) mentioned. Different CBs charge their own fees depending on their credit rating.
You can implement the standard requirements internally and using your knowledge and experience in the laboratory. You can also use the ISO13485 standard consultation of the modirfa team to speed up the implementation of the requirements and also use the experiences of the modirfa team. . You can contact us to get more information about ISO13485 standard consulting fee.
Procedures for obtaining ISO13485
In order to receive the ISO13485 standard, you must first implement the requirements of the standard in your organization and also have at least one technical person in charge based on the type of product or service you provide. After implementing the requirements and preparing for the audit, you specify your CB certification company and sign a contract with them.
A very important point that you have in choosing a certification company is choosing CB. When choosing CB, you must choose one of the companies approved by the General Department of Medical Equipment IMED. The top organization in the field of medical equipment in Iran is the General Directorate of Medical Equipment. So you should choose your certification company based on the approved list of this organization.
Beware of unlicensed and fraudulent organizations.
Be sure that if an organization gives you an ISO certificate without implementing it in your organization and conducting an audit, it must be a fraud.