ISO 13485:2016 Certification

ISO 13485:

The international standard ISO 13485 provides requirements particularly to improve the quality management system of the organizations that provide medical devices and equipment. It specifies control measures to reduce operational errors in the manufacturing process and system. Also, this standard ensures the continual improvement in the quality of medical equipment.

Who can apply?

Regardless of size, the requirements of ISO 13485 standard are applicable to all companies/industries that manufacture and deliver medical devices and equipment. Also, this standard applies equally to the industries that provide related services.

Benefits of Certifying to ISO 13485:

  • The ISO 13485 certification promotes the organization’s QMS performance
  • Develops the quality of medical devices
  • Reduces wastes and operational errors
  • Promotes customers confidence
  • Strengthens the relationship with stakeholders
  • Also, creates new business opportunities

A well-known ISO 13485 certification body in UAS – IAS

About us:

IAS is the most trusted ISO 13485 Certification body in United States of America. We offer ISO 13485 certification services effectively for more than 13 years to all organizations that have a well-developed operational process and management system. Also, we make our clients happy and satisfied by providing proper guidance in the implementation of the required ISO 13485 criteria and the achievement of the ISO 13485 certification.

Real-time auditors:

Our auditors are professional experts who have years of experience in management system audit and versatile knowledge of ISO standards. They guide the organization expeditiously to improve the ISO standard requirements quickly and as well as flawlessly. Also, IAS acts as an ISO 13485 certification consultant to help the organization in the preparation process.

Global presence:

IAS is a globally recognized platform, located in India. IAS has its local organizations in Malaysia, Singapore, and so on. We also have several branches and representatives in various countries across the world to provide ISO 13485 Certification services.

Other than USA, IAS also offers ISO 13485 certification service in Bangladesh, Vietnam, Philippines, Thailand, Gulf countries such as Oman, Qatar, Kuwait, Bahrain, Latin American countries including Mexico, Brazil, Peru and European countries such as France, Italy, Germany and also in African countries such as Morocco, Nigeria, Ghana, and so on.

How to contact us?

There are plenty of ways to reach us.

  • Visit our website –
  • Send us your enquiry through our website
  • Drop a mail to
  • You can also fill out our ISO 13485 Certification application form and send us
  • Or else contact us directly to have free discussion about the auditing process specific to your organization

For detail discussion over phone or in-person, kindly contact our executives through Mail: info@iasiso,com or Mobile:+91 9962590571