ISO 13485 Certification in Kuwait

 

In today’s blog I will be taking you through ISO 13485 certification in Kuwait; ISO 13485 standard deals with Medical Devices – Quality Management System. I will explain you the details of this standard, benefits of it and its implementation in The State of Kuwait. International Organization for Standardization popularly known as ISO is an independent global organization that is involved in the process of setting international standard for almost everything right from finished products, technology, and food safety to medical devices etc. It was founded in the year 1947 and has grown leaps and bounds from then on; currently it has members from across 167 countries that meet annually at the General Assembly to discuss future strategies and their implementations.

Medical Device - Quality Management System


Details about ISO 13485

ISO 13485 standard deals with Medical Device – Quality Management System; it is dedicated for those organizations who are involved in the manufacturing and distribution of medical devices. This standard is designed to check the quality of the medical devices at any stages of the product life cycle. The latest version of this standard was published in the year 2016 and it supersedes the previous edition which was published in the year 2003. Since the latest version of the standard was published in the year 2016 it is also represented as ISO 13485:2016 which is the official name for it. ISO 13485 standard is applicable to any organization irrespective of the size of the organization, given the fact that the organization is involved in the process of manufacturing and distribution of medical devices.

Benefits of getting ISO 13485 certified

Getting ISO 13485 certified has multiple benefits; I will try to lay down a few of them for you below.

·        It gives an international recognition to your organization as the quality of medical devices manufactured by you is complied with international standards.

·        Since, ISO 13485 is concerned with medical devices manufacturing the safety of patients depend on the quality and consistency of medical products so maintaining the QMS is critical to patients, stakeholders, regulatory agencies etc.

·        It helps in increasing the efficiency of internal process as the quality of the product needs to be top notch.

·        This certificate establishes the credibility of your organization and hence the explanation of the product features and its specification becomes more straightforward thus increasing the sale and profit.

ISO 13485 in Kuwait

The State of Kuwait popularly known as Kuwait is a country in the Middle East which is surrounded by the Persian Gulf on one side and it shares its land borders with Saudi Arabia and Iraq. Kuwait is one of the most flourished nations of the world hence it becomes important to discuss ISO certification in Kuwait.

The economy of Kuwait is mostly driven by its oil export and has most affluent population living in this part of the world. The medical standards of such affluent societies need to be top notch and ISO 13485 helps in achieving this feat.

About Finecert  

ISO 13485 has become one of the most important standard for medical device manufacturing industries; this standard act as an added advantage and helps improve the credibility of the organization. It serves as a benchmark for the quality of products manufactured by the organization and establishes a name for itself. Having explained everything related to ISO 13485 let me add one more thing that ISO only sets standard and is not involved in the process of lending certificates this is done by external bodies.

Finecert is one such leading global organization that has expertise in providing ISO certification and consultation. We employ a cost effective model for our clients, check ISO in Kuwait and build a long term relationship with them. We have a team of highly trained consultants that can solve any of your queries related to ISO certification. We at Finecert aspire to provide best client experience and help their organization get ISO certified in the given or less than that time frame. We have a global presence and we employ a very transparent approach in dealing with our clients and integrity for us is of utmost virtue.

To know more about ISO 13485 certification and consultation for your organization, you can write to us or request a quote at contact@finecert.com or you can visit our website www.finecert.com and take a look at the services we offer.

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