What are the requirements for the process of ISO 13485 Certification in Saudi Arabia? - Factocert - The Best ISO Consultant Company
ISO 13485 Certification in Saudi Arabia

What are the requirements for the process of ISO 13485 Certification in Saudi Arabia?


ISO 13485 Certification in Saudi Arabia follows – quality management systems (QMS) for medical devices for regulatory purposes. The latest ISO 13485:2016 specifies guidelines on how to demonstrate to regulators that an organization can provide medical devices and related services per regulatory requirements. The ISO 13485 standard provides an effective framework to meet the comprehensive needs for a medical device quality management system in Saudi Arabia.

 Medical device manufacturers should appoint an experienced ISO 13485 consultant to work on all risk-class devices. Organizations must monitor the safety and risk information during the product life cycle per ISO 13485 requirements. 

What do we do as ISO 13485 Medical Device Consultants in Saudi Arabia?

We guide our clients in designing and implementing 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.

Requirements of ISO 13485 2016 Certification

Unless otherwise specified, the requirements of ISO 13485:2016 apply to all organizations, regardless of their size or type. Any conditions 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 per Saudi Arabia’s norms and any additional regulatory requirements 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 company’s size, the product’s risk classification, and applicable exclusions and non-applicability.

An organization needs to demonstrate, through ISO 13485 Certification Requirements, that the products and services it provides meet customer expectations. ISO 13485 certification means that an organization has been able to demonstrate the following:

  •  Ensures compliance with ISO 13485
  •  Ensures that the requirements are met
  •  Complies with statutory and regulatory requirements as well as customer requirements
  •  Ensures documentation is up-to-date

ISO 13485 Certification Standard Benefits

  • By obtaining certification, you can gain access to a wider market around the world. 
  • Provide an overview of your organization’s processes and how they can be improved. 
  • Improve supply chain performance, reduce costs, and increase efficiency. 
  • Show that the medical devices you produce are safer and more effective. 
  • Meet regulatory requirements and customer expectations. 

As part of the ISO 13485 standard, manufacturers can develop and maintain quality management systems that establish and maintain a manufacturer’s processes to ensure that medical devices and related services are safe for their intended purposes by consistently creating and developing, producing, installing, and delivering them.  

Certification Cost of ISO 13485 Certification in Saudi Arabia:

The cost of ISO 13485 certification varies depending on criteria such as the organization’s size, the complexity of activities, and the certifying body chosen. On the other hand, the benefits of certification usually surpass the costs. ISO 13485 certification can also increase operational efficiency, customer trust, and market competitiveness. Furthermore, certified organizations may benefit from lower compliance costs and greater access to international markets. To summarize, despite the initial costs, the advantages of ISO 13485 certification make it a viable venture for many businesses.”

Obtaining ISO 13485 certification is a big deal for the medical device industry in Saudi Arabia. It helps the industry grow and contributes to the country’s economy. Companies that follow ISO 13485 standards ensure that their medical devices are of the highest quality. This boosts their credibility and makes it easier for them to sell their products internationally. Factocert, a company that knows the ins and outs of certification, can guide businesses through the ISO 13485 process. This means companies can confidently start their journey towards ISO 13485, aiming for excellence in their work.

ISO 13485 Certification Process in Saudi Arabia

Factocert ensures that the ISO 13485 Certification Process in Saudi Arabia is kept simpler and very easy to implement. We also provide online plus onsite assistance at the time of consulting to ensure that our clients get a better understanding of the entire process before the final assessment.

Our agenda is to provide cost-effective, competitive, and practical business solutions to help organizations quickly achieve ISO 13485 Certification in Saudi Arabia. We are one of the leading IT consulting companies with international customers and services that cover all the International Quality Certifications such as ISO 27001, CMMI, EU GDPR, HIPAA, SOC 1, SOC 2, and other important cyber security standards.

The differences between Saudi Arabian ISO 9001 and Saudi Arabian ISO 13485 certification

  • Generally, ISO 9001 applies to many industries, but the ISO 13485 standard only applies to medical device manufacturers and traders.
  • Undoubtedly, ISO 9001 has gained international recognition as a standard for quality management systems. Still, adding to this in ISO 13485, more emphasis is given to additional requirements specific to the companies that manufacture medical devices.
  • Certain specific sets of requirements are present in the ISO 13485 standard, such as documentation requirements for medical device files, work environment, compliance with regulatory authorities, production and contamination control, sterile medical device requirements, and the cleanliness of products.

Why Choose Factocert?

We provide the best ISO consultants in Saudi Arabia, Who are very knowledgeable and provide you with the best solution. And to know how to get ISO certification in Saudi Arabia? Kindly reach us at contact@factocert.com ISO Certification consultants follow the guidelines set by the international organization for standardization and help the organization to implement ISO certification in Saudi Arabia in an easy way with proper documentation and audit.

For more information visit: ISO 13485 Certification in Saudi Arabia

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