ISO 13485 Certification Companies for medical device producers

Posted by Dave on October 29th, 2021

ISO13485 is designed to be used by Companies  involved in the design, production, installation and servicing of medical devices and related services

 produced  both for national and international certification.

 All family of standard based on theISO 9001 international standard, the goal is to voluntarily meet all recognized quality management standards in North America, Europe, Brazil, Australia and many other countries. Through our ISO 13485 Certification Companies, your company can display this ISO standard, which is recognized in the USA by the good manufacturing practices quality management system.

The Industries Involved

Direct  ISO 13485 registration bodies companies and businesses that are indicated in designing, developing and producing medical devices, and also related products and services, have the opportunity to display their attachment to these standards.

Companies working in the field of the design, development and production of in vitro medical devices, inserts and other types of medical devices wanting to do business internationally.


The Certification Process

By operating with our ISO 13485 Certification Companies,we will work with you to make sure that  your practices and standards are gathering those of the ISO standards. This contains the development of written policies for problems such as internal audit procedures, corrective and preventive actions, process and design controls, record controls and retention as well as accountability through all aspects of production.

There are enough  benefits to a company in using our ISO 13485 registration service. Companies obtaining this voluntary certification will be able to enlarge their markets, improve the planning of their production systems, and make their products to a higher quality with increased consistency.

Use Our ecomomical  ISO 13485 Certification Companies Approach

We give the ISO certification you need with no hidden fees. You can expect to profit from our high standards concerning diploma and certification.  At International Quality Certification we are ready to help  you in every manner when it comes to ISO certification and quality management systems.

ISO 13485:2016 specifies requirements for a quality management system where an organization requireds to indicate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This type of  organizations can be complicated  in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device. To know more visit us at

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Joined: February 1st, 2021
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