ISO 13485:2016 on Medical Devices

The ISO 13485 standard for Medical devices is a Quality management system defined for the industry. The standard covers the necessities of the regulatory bodies, addresses the growth and progress, implementation and maintenance of a quality management system needed for use by medical device manufacturers and suppliers.

The standard was developed in the 1990s, the standard details requirements for a quality management system that meets both customer requirements and regulations around the world.

ISO 13485 standard is quite analogous in scope and implementation to ISO 9001, but it also contains supplementary requirements that are precise to medical devices while excluding certain ISO 9001 provisions. Hence, in many countries, ISO 9001 certification is not an acceptable standard where ISO 13485 standard is applicable for the scope of the organization.


  1. The certification helps your organization enhance and optimize the processes effectively and efficiently, therefore enabling you to showcase your products and services and build the goodwill.
  2. Our team comprises of professionals from the specific industries which helps the organization in analyzing the opportunities and threats associated to the environment.
  3. The standard certification gives a unique solution to all the compliance requirements in coherence with international standards and regulations that are appropriate for the industry.