ISO 13485 Certification

ISO 13485 CERTIFICATION – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM

Move ahead with the best picture quality management system for medical devices. Get your medical devices’ quality certified by ISO 13485 with the help of Ascent EMIRATES.

What is ISO 13485 Certification?

The ISO 13485 is the medical devices quality management system. Medical devices are one of the most important parts of the medical system. It’s impossible to move ahead without them. But the quality of the devices always creates a major concern.

The standard specifies all the directives and requirements needed to maintain quality. In many countries around the world, only ISO 13485 does not suffice for selling a medical device. It may also require a clearance from the local body.

The latest version of the ISO 13485 is the ISO 13485:2016.  This describes the current QMS requirements for the organizations related to medical devices. 

Besides, we have a widespread recognition over the areas of ISO 13485 Certification viz: Abu Dhabi, Dubai, Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah and Fujairah.

Importance of ISO 13485 Standard Certification :

The population of the world is growing. With this, there is an increase in health-related issues. Public health, these days, is one of the top priorities for the government. For this, a large number of medical facilities have been set up in every country around the world. The government of almost every country around the world has put the utmost importance on public health.

ISO 13485 certification ensures a QMS for organizations related to medical devices and it makes sure that the operations in the organization are compliant and adheres to the directives, requirements and regulations. 

Benefits of ISO 13485 Certification:

The advantages of ISO 13485 certificates in UAE are not for the present day, but their significance can be seen further in long run for an organization or a firm that accept the quality standard for medical devices and services. 

The ISO 13485 certification benefits include:

  • Meeting the requirements- The standard ensures that an organization remains adhered to the directives set by it and also meets the desired requirements regarding product quality.
  • Enhanced reliability- It enhances the credibility and trustworthiness of an organization. This means that the brand is more welcome around the world. Being certified to the standard enhances the affinity of the customer towards the organization. A customer will prefer a certified organization over a non-certified one.
  • Product performance- It increases the performance of the products to meet the standard of the ISO 13485 in Dubai. To meet the requirements of the standard, an organization has to upgrade the quality of the product.
  • Competition- The certification gives an organization the advantage in competition by increasing business stability. It gives the certified organization an edge over non-certified ones.
  • Manpower- This creates a proper system to monitor the performance of the personnel working within the organization.
  • Procedural ease – The procedure of certification is a very simple and lucid. For that, the certification becomes a lot easier.
  • Customer Satisfaction – A business that can work without any kind of disruptions can always bring more customer satisfaction through smooth operations.
  • Brand Value – Brand value is a key to every business. Operating without any potential disruptions often sets a high brand value for a business body.

Requirements of ISO 13485 Certification:

The ISO 13485 has a set of directives, guidelines, and requirements. Following these requirements enables an organization to successfully implement the standard.

  1. The plan and need must be determined.
  2. Identification of quality management systems in the medical process and procedures.
  3. Prepare all the documents that are required to fulfil the need of the standard.
  4. Regular maintenance of medical devices.
  5. Timely sanitization of devices.
  6. A yearly internal audit of an organization.

Strength of Ascent EMIRATES

Ascent EMIRATES is a leading consultancy for the ISO 13485 Quality Management System in UAE, Oman, & Saudi Arabia.

  1. Help you in assuring that your product quality is compliant to the standard and acquire the certificate. 
  2. Helps to acquire the certificate without any difficulties and with an easy documentation process. Ascent will help you to have the certification done in the simplest way.
  3. Has qualified ISO 13485 lead auditors with a professional attitude to handle your various problems related to conformity and certification of compliance.
  4. Works 24*7 for their customers and clients with a simple motto, “No extra cost than the offered fees” to an organization.
  5. Explains the importance and implementation of the standard.
  6. Trains and guides you throughout the process to achieve the certification.
  7. There is no compromise when it comes to the quality of your medical devices, that is why you can trust Ascent EMIRATES by providing reliable and innovative solutions to your problems.

Get in touch with Ascent EMIRATES, to have the best ISO 13485 Quality Management System in UAE, Oman, & Saudi Arabia today! So, connect with our expert advisory team @ uaeoffice@ascentworld.com to learn more. Dial : +971-4-4558490 to avail Best Offers.

Frequently Asked Question

What is the duration required to avail ISO 12485 Certification?

The time it takes to obtain the ISO 13485 Certification in Oman depends on the size of the organization. In case of smaller organization, it can be done within 3-4 months, whereas in case of larger organization it can take from 8 months up to a couple of years.

What is the total time required for obtaining an ISO 13485 Certificate?

Well, the ISO 13485 Quality Management System process in Sharjah depends on different factors such as strength of your organization, documentation, approvals, auditing, and other clarities. Give or take, you will get your certificate within 3 to 6 months. 

What is the validity of ISO 13485 Certification?

After doing different types of work for ISO 13485  in regions like the UAE, Oman, Saudi Arabia, it is valid for a certain time. Well, the validity of this certification is for 3 years. 

How do you define class 1, 2, and 3 medical devices?
As per FDA, medical devices have classified into three different categories. 

They are as follows:

  1. CAT 1 / CLASS I: Devices to use with general control at low risk. 
  2. CAT 2 / CLASS II: Medical devices available on general store at moderate risk. 
  3. CAT 3 / CLASS III: Medical devices with high risk for sustaining life. 

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