ISO 13485

ISO 13485 is an international standard for businesses that manufacture medical devices. The standard specifies the medical device regulatory requirements for the design and manufacture of medical devices. It ensures that medical equipment manufacturing companies meet international quality, safety and legal requirements in professional manner. The certification results in increased customer satisfaction, improved stakeholders relationships, improved risk management and high reputation of business. We serve the entire country of KSA covering Makah, Medina, Riyadh, Jeddah, Khobar and Dammam.

Why more and more medical equipment manufacturing companies are seeking ISO 13485 certification?

It is the importance of this certification that more and more businesses are seeking ISO 13485 certification. The certification is meant for all types of organizations that are involved in any tier in the medical device and pharmaceutical supply chain. This standard is important for business for a several reasons.


  • Since safe and secure work environment is necessary for all businesses, the certification helps companies in establishing the most secure and safe work environment to manufacture medical devices.

  • The certification also plays a highly significant role in risk management activities and design control activities.

  • Furthermore, it is an effective check over the specific requirements for documentation and validation of processes that are necessary for sterile medical devices. In short, this certification improves any organization's competitiveness.

Speaking of benefits of ISO 13485 certification, it has several benefits such as meeting customers’ needs more efficiently, enhancing operational efficiencies by reducing operating costs, having improved relationships with customers, suppliers and the employees, enabling the business to meet legal requirements and eliminating wastes. We serve the entire country of KSA covering Makah, Medina, Riyadh, Jeddah, Khobar and Dammam.

Why US?

We are a leading ISO consultant company and have been providing our clients the best ISO certification services. There is a good reason why we have a large number of satisfied clients. We offer proven and proprietary implementation and training support for ISO 13485 certification. Our highly professional consultants and auditors are qualified enough to help our clients in successfully implementing ISO 13485 standards and eventually achieving the certification.

Contact us today for more details.