ISO 13485 medical devices QMS in UAE

Home ISO 13485 – Medical Devices QMS

ISO 13485 - Medical Devices QMS in UAE

Sterling International Consultants simplify your task to achieve the global quality management standards, appearing all the more reliable to your customers. The process in this regard is not that simple. Rather, your company needs to pass through layers of challenges and hardships before you can achieve the accreditation standard. It is where we can extend the most effective assistance to your company.


We offer turnkey solutions, helping our clients to reach the standards specified in the ISO guidelines. Our company holds a formidable track record about assisting our clients in achieving the certification standards, winning the complete faith and confidence of your target customers. Today, we are the leading consultancy for ISO 13485 Certification in UAE. 

What is the ISO 13485 Certification in UAE?

The ISO 13485 Certification in UAE is a quality management system for Medical Device companies. This accreditation applies to the companies involved in the design, production, installation, and maintenance of the medical devices and services related to it. Besides, these guidelines set up a globally-accepted guideline for internal and external parties for the auditing process.


The focus areas of the ISO 13485 Certification in UAE come as follows:

  • Seamless delivery of medical devices and services to customers.
  • Adopting model practices across areas like design, development, and installation of medical devices.
  • Offering superlative maintenance support services to customers.
  • Complete compliance with regulatory, statutory, and legal compliance revolving around healthcare services.
  • Development of a comprehensive framework to identify the key areas of risks and threats.
  • Consequently, developing a robust mechanism to offer the most relevant solutions to the foreseen and unforeseen challenges and risks.
  • The objective of the ISO 13485 Certification in Dubai is to facilitate better-informed decision making.

We are the most coveted consultancy for ISO 13485 Certification in Dubai.

Benefits of ISO 13485 Certification in Abu Dhabi

The ISO 13485 Certification in Abu Dhabi develops a guideline that directs your organization to ensure the optimum quality of your products.

Complying with this guideline, your organization adopts the best practices in serving the customers.


The overall outcome is that it enables you to delight your customers, and thus secure the best engagement between the brand and its customers.


It enhances the productivity, efficiency, and management functions of your organization, helping the brand to move to the next level

How to get ISO 13485 Certification in Abu Dhabi Dubai UAE?

ISO 13485 certification in dubai can be achieved by contacting an approved certification body and implementing a quality management system to mintigate the risks, improve standardization and ensure traceability by contacting an ISO 13485 consultant at


Sterling International helps its customers to achieve complete compliance for the ISO 13485 Certification in Abu Dhabi. Once you engage our consultancy for guiding you through the accreditation process, it starts with sending a complete proposal. After we get your confirmation, we will prepare the project document that will guide your efforts and endeavors for the certification. We help you in preparing the documents and registers, and we deploy a dedicated project manager who will keep guiding your efforts and endeavors for the accreditation.

Documents Required for ISO 13485 Certification in Abu Dhabi

  • Quality Manual
  • Medical Device File
  • Record Control Procedure
  • Quality Policy and Objectives
  • Authorities and Responsibilities
  • Management Review- procedure and records
  • Infrastructure guidelines
  • Risk Management guideline

What can Sterling International offer for the QMS accreditation?

We handle the complete scope of work in helping your organization achieve the accreditation. Our expertise and experience in QMS Consulting simplify the task of our clients to match the certification standards. Most importantly, we help our clients to overcome the unproductive expenses towards the certification. On the whole, we stand beside our clients to help and guide them in getting the accreditation within the minimum time.