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ISO 13485 Certification

ISO 13485 Certification in Egypt

 IAS – the famous ISO 13485 Certification body in Egypt

Integrated Assessments Services (IAS) provides globally recognized ISO 13485 Certification in Egypt. We are accredited by UQAS for providing management system certification as well as product certification. Our auditors are certified lead auditors and skilled experts in providing required guidance to the journey of achieving standardization for your organization. 

With more than 13 years of professional experience in auditing and issuing certification, IAS supports its clients effectively to implement the management system and to acquire the desired ISO Certification.

Overview – ISO 13485 Management System standard

ISO 13485 is a special ISO standard for establishing, monitoring, maintaining, implementing, and continually improving the quality of medical devices and equipment. The requirements of ISO 13485 are intended to be applicable to the Quality Management System of the organizations that develops and delivers medical devices, related equipment as well as associated services. This ISO quality management system standard also includes similar requirements as ISO 9001. The major difference in ISO 13485 is, it specifies requirements to enhance the quality performance of medical devices and equipment.

About ISO 13485 Certification

Achieving ISO 13485 Certification not only enhances the medical device quality but also promotes the performance of its associated services. It shows an organization’s involvement in developing high-quality medical equipment. This ISO 13485 Certification for medical devices ensures products’ quality, safe performance as well as employees’ safety. This also enhances the customers’ confidence in your medical devices, processes, and system.

As ISO 13485 has a similar connection with ISO 9001, it is easy to implement with the existing ISO management system. ISO 13485 Certification outshines your organization’s effective performance globally and helps meet more potential clients even from overseas.

Why is ISO 13485 Certification important?

  • The ISO 13485 Certification ensures medical devices quality and their robust performance
  • Ensures consistency and reliability
  • Helps meet legal quality requirements
  • Reduces waste as well as operational cost
  • Improves customer satisfaction
  • Convinces stakeholders to trust your products and services
  • Also, promotes the business and organizations’ reputation

What are the other services of IAS?

IAS is a top-searching ISO Certification body in Egypt for providing product certifications. We offer product certifications such as CE Marking, Green, GOST-R, Kosher, Halal, BRC, CGMP, and so on.

IAS is also a popular ISO training platform in Egypt and we offer lead auditor training, internal auditor training, and as well as awareness and foundation training courses on various ISO management system standards such as ISO 9001, 14001, 22000, 50001, 13485, etc.

Kindly contact us to know more about the ISO 13485 Certification and its auditing process.