ISO 13485 Certification Services For Medical Device Manufacturers

Posted by Dave on March 15th, 2021

At International Quality Certification, we can give the ISO 13485 certification service needed for medical device producers  both for national and international certification.

As with this whole family of standards, all 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 Services registration service, your company can display this ISO standard, which is recognized in the USA by the good manufacturing practices quality management system.

The Industries Involved

Through ISO 13485 certification 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 Services,we will work with you to make sure that  your practices and standards are gathering those of the ISO standards. This comprises the development of written policies for issues 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 a lot of 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 Cost Effective ISO 13485 Certification Services 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. We provide you the international opportunities you require with the assistance from our knowledgeable auditors. 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 needs for a quality management system where an organization needs to indicate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be intricate  in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.