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ISO 13485 medical devices QMS in UAE

Home ISO 13485 – Medical Devices QMS

ISO 13485 -Certification in UAE - Dubai & Abu Dhabi

Sterling International Consultants simplify your task to achieve the global quality management standards. While the process is not simple, it pays off when your business appears all the more reliable to your customers. To get ISO 13485 certification, your company needs to pass through layers of challenges before you can achieve the accreditation standard. It is where Sterling International Consultants 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 of 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 the UAE.

ISO 13485 - Medical Devices QMS in UAE

What is ISO 13485 Certification ?

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


The focus areas of the ISO 13485 Certification in UAE are 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.
  • Developing 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.
  • One of the core objectives of the ISO 13485 Certification in Dubai is to facilitate better-informed decision making.

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

Benefits of ISO 13485 Certification in Abu Dhabi

The ISO 13485 Certification allows you to adhere to a set of guidelines that direct your organization to operate in compliance with international standard procedures. It  helps ensure the optimum quality of your products.

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


The overall outcome enables you to gain the highest levels of customer staisfcation, and thus secure the best engagement between the brand and its customers.


Not to mention, it also enhances the productivity, efficiency, and management functions of your organization, helping the brand to move to the next level

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

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

The first step to get an ISO 13485 certification in Dubai is to contact an approved certification body and start implementing a quality management system to mitigate the risks, improve standardization and ensure traceability. You can start  by contacting an ISO 13485 consultant at info@uaeiso.com.


At Sterling International, we help our customers achieve complete compliance for the ISO 13485 Certification in Abu Dhabi. Once you engage our consultancy for guiding you through the accreditation process, you receive a complete proposal. After we get your confirmation, we will prepare the project document that will guide your efforts and endeavors for this certification. We help you prepare the documents and registers, and we also deploy a dedicated project manager who guides 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

How Sterling International Helps With 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 tasks that could overwhelm our clients to match the certification standards. Most importantly, we help our clients overcome the unproductive expenses towards the certification. On the whole, we stand beside our clients throughout the process and guide them to get the accreditation within the minimum time.