ISO 13485

ISO 13485 (ISO standard for quality management of medical equipment)



Benefits of receiving ISO 13485 certification

  • Ensure the health of medical products and equipment
  • Globalization and creating a competitive advantage in exports
  • Receive a valid international certificate with a registration code
  • Create a sense of confidence in customers
  • More and more effective sales due to brand strengthening
  • Suitable and standard conditions for medical products


What is the standard and certification of ISO 13485?

In order to obtain ISO 13485 certification, RoseCal Consulting is ready to provide services to companies and organizations. (Receiving ISO 13485 – Issuing ISO 13485 – Receiving ISO 13485 – Obtaining ISO 13485)

ISO 13485 standard and certification is a specialized standard for companies producing medical and surgical equipment and tools.

The companies that succeed in receiving this certification indicate that they have complied with the quality requirements approved by the International Organization for Standardization in the production of their medical products.

All medical products related to consumables such as sutures and bandages to medical devices can receive the certification of this standard by observing the requirements of ISO 13485 standard.


The importance of obtaining ISO 13485 certification in the medical industry

ISO 13485 certification (quality management system in medical equipment) focuses on a quality management system in the design, development, production, assembly, after-sales service and distribution of medical equipment and facilitates the process of obtaining the CE mark for export to Europe.

Products that succeed in obtaining ISO 13485 certification and CE mark will be able to be exported to Europe.

At present, the General Directorate of Medical Equipment of Iran has determined a limited number of approved companies, and ISO System is also a party to some of these centers.

Therefore, if you wish, you can receive the ISO 13485 certificate and the CE mark approved by the General Directorate of Medical Equipment through the ISO system.


Purpose of implementing and obtaining ISO 13485 certification

The purpose of implementing and enforcing the ISO 13485 standard is to establish coordination in the requirements and implementation of quality management rules and regulations for the medical equipment industry.


Application of ISO 9001 and ISO 13485

This standard, along with ISO 9001 (quality management system) or IMS integrated management system, is very complementary and will bring excellence to medical equipment companies.

Contrary to ISO 9001, the international standard ISO 13485 eliminates the emphasis on continuous improvement and customer satisfaction and instead focuses on issues such as adapting to customer needs, risk management and maintaining effective processes such as specific processes such as safe design, production and The distribution of medical equipment is emphasized.

ISO 13485 certification is useful for creating a management system in accordance with customer requirements, especially global laws.

Of course, it should be noted that despite the differences mentioned between ISO 9001 and ISO 13485, the nature of these two standards is based on the Deming cycle and process-based.


Obtaining ISO 13485 – Issuing ISO 13485 – Receiving ISO 13485

To obtain ISO 13485 (receiving ISO 13485 – issuing ISO 13485) you can apply through the RoseCal Consulting. RoseCal Consulting is the top center for obtaining ISO 13485 (receiving ISO 13485 – issuing ISO 13485) in the country with the official license of the Industry, Mining and Trade Organization.

To obtain ISO 13485 certification (Receive ISO 13485 – Issue ISO 13485) Apply through the link to apply for a certificate on this page. You can also apply for ISO 13485 (Receive ISO 13485 – Issue ISO 13485) through this link quickly. register.