ISO 13485 Standard – QMS for Medical Devices in Egypt

Egypt uses the ISO 13485 standard – quality management systems (QMS) for medical devices for regulatory purposes. Since this is an industry-specific standard, it applies to device makers, distributors, retailers and importers in the medical sector. 

The ISO 13485 standard provides an effective framework to meet the comprehensive requirements for a medical device quality management system. Manufacturers and service providers must both comply and demonstrate their compliance with regulatory requirements. Medical device manufacturers should appoint an experienced ISO 13485 consultant who can work on all risk-class devices.

As an ISO 13485 guidance consultant, Operon Strategist provides services like implementation, documentation, gap analysis, training and registration process for the ISO 13485 certification.

The ISO 13485 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system. Manufacturers and service providers both must comply and demonstrate their compliance with regulatory requirements. The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers.

Medical device manufacturers should appoint an experienced ISO13485 consultant who can work on all risk class devices. The organizations need to monitor the safety and risk information during the product life cycle as per ISO 13485 requirement.

ISO 13485 certification

What are the Requirements of ISO 13485:2016 in Egypt?

The requirements of ISO 13485:2016 apply to all organizations, regardless of their size or type, unless otherwise specified. Any requirements that apply to medical devices also apply to associated services provided by the organization.

The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.

While implementing the system, it is necessary to know the local applicable regulatory requirements as per Egypt’s norms and also any additional regulatory requirements, which you may have to comply with due to an export of the product. When designing the QMS as per ISO 13485, it is also necessary to understand the size of the company, the risk classification of the product and applicable exclusions and non-applicability.

Benefits of ISO 13485

  • Increase access to more markets worldwide with certification. 
  • Outline how to review and improve processes across your organization. 
  • Increase efficiency, cut costs and monitor supply chain performance. 
  • Demonstrate that you produce safer and more effective medical devices. 
  • Meet regulatory requirements and customer expectations. 

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How to Get ISO 13485 Certification in Egypt? 

The ISO 13485 certification bodies in Egypt support a quality management system that establishes and maintains effective manufacturing processes. These processes must ensure consistent medical device design and development, production, installation, as well as delivery of medical devices, or related services, that are safe for their intended purpose.

Stept for ISO 13485 standard

Our experience as ISO 13485 consultants will provide guidance to easily get the ISO 13485 certification. We set up a step-by-step process with zero errors. First, we provide a special screen-sharing module which helps the manufacturer in the creation of documents such as SOPs, Quality manuals and Process validation documentation. After that, we provide assistance and training to make sure that the system is adequately implemented.

What do we do as ISO 13485 Consultants?

We make sure that our clients not only get the benefits of ISO 13485 certification for their organization but also understand QMS regulations & requirements. We guide our clients in implementing ISO 13485 standard QMS by:

  • Identifying regulatory requirements as per the class of the device.
  • Defining the documentation required in the process. 
  • Providing training on QMS. 
  • Establishing standards stage-wise.

Why Operon Strategist? 

  • We provide cost-effective services. 
  • Timely and error-free deliverables.
  • During the implementation process, we identify the specific regulatory requirements for the product, such as MDR and FDA 510(k).
  • We follow a well-defined work methodology to implement organized working leading to zero-errors and higher-efficiency.

Discuss with us (enquiry@operonstrategist.com) to get best quotes. 

We also provide medical device consultation for India, South Africa, Egypt, the USA, the UK, Costa Rica, Oman, and Iran. For free consultation Contact us now.