ISO 13485

ISO 13485, an international standard for medical devices, specifies all the regulatory requirements for the design and manufacture of medical devices. This global medical standard for quality and competence is very important for business involved in manufacturing health and medical devices. It not control and improves the process of medical device manufacturing but also keeps a check on the quality of design of the devices.

Why this certification is gaining popularity with every passing day?

The certification has become so popular that more and more medical equipment manufacturing companies are seeking it. Who needs this certification? ISO specifically designed this certification for organizations that are involved in any tier in the medical device and pharmaceutical supply chain. As we know, manufacturing of medical devices is very critical thing and it requires safe and secure work environment. With the help of this certification, you become able to establish the most secure and safe work environment to manufacture medical devices.


If your company is involved in any tier in the medical device and pharmaceutical supply chain, the certification offers the following benefits for your business:

  • It plays an important role in risk management activities and design control activities.
  • It improves any organization's efficiency and competitiveness
  • It helps companies in meeting customers’ needs efficiently
  • It reduces operating costs by eliminating wastes
  • It improves relationships with your customers, suppliers and the employees